Financial Statements
−Removed: THERAPEUTICS, INC.
+Added: ORUKA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
−Removed: September 30,
Current assets:
Cash and cash equivalents
−Removed: Subscription receivable
+Added: Marketable securities, current
Prepaid expenses and other current assets
Total current assets
+Added: Marketable securities, long-term
Property and equipment, net
−Removed: Operating lease right-of-use asset
+Added: Operating lease right-of-use assets
Other non-current assets
10 unchanged sentences
Commitment and contingencies (Note 11)
−Removed: Series A convertible preferred stock, $ 0.0001 par value;
−Removed: no shares and 20,000,000 shares authorized as of September 30, 2024 and February 6, 2024, respectively;
−Removed: no shares issued and outstanding as of September 30, 2024 and February 6, 2024;
−Removed: liquidation preference of $ 0 as of September 30, 2024 and February 6, 2024
−Removed: Series A non-voting convertible preferred stock, $ 0.001 par value;
−Removed: 2,439 and no shares authorized as of September 30, 2024 and February 6, 2024, respectively;
−Removed: 2,439 and no shares issued and outstanding as of September 30, 2024 and February 6, 2024, respectively
Stockholders’ equity:
Series B non-voting convertible preferred stock, $ 0.001 par value;
−Removed: 251,504 and no shares authorized as of September 30, 2024 and February 6, 2024, respectively;
−Removed: 137,138 and no shares issued and outstanding as of September 30, 2024 and February 6, 2024, respectively
−Removed: Common stock, $ 0.001 and $ 0.001 par value as of September 30, 2024 and February 6, 2024, respectively;
−Removed: 545,000,000 and 65,000,000 shares authorized, 34,998,550 and 3,197,975 shares issued and outstanding as of September 30, 2024 and February 6, 2024, respectively
+Added: 251,504 shares authorized as of March 31, 2025 and December 31, 2024;
+Added: 137,138 shares issued and outstanding as of March 31, 2025 and December 31, 2024
+Added: Common stock, $ 0.001 par value;
+Added: 545,000,000 shares authorized, 37,440,510 shares issued and outstanding as of March 31, 2025 and December 31, 2024
Additional paid-in capital
+Added: Accumulated other comprehensive loss
Accumulated deficit
1 unchanged sentence
Total liabilities, convertible preferred stock and stockholders’ equity
−Removed: accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: THERAPEUTICS, INC.
+Added: The accompanying notes are an integral part of
+Added: these condensed consolidated financial statements.
+Added: ORUKA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
−Removed: Three Months Ended
−Removed: September 30,
(Inception) to
−Removed: September 30,
Operating expenses
6 unchanged sentences
Interest expense (3)
+Added: Other expense, net
Total other income (expense), net
−Removed: Net loss and comprehensive loss
+Added: Net change in unrealized gains (losses) on marketable securities
+Added: Comprehensive loss
Net loss per share attributable to common stockholders, basic and diluted
−Removed: Net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted
−Removed: $ ( 1,461.10 )
−Removed: $ ( 6,077.25 )
Net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
−Removed: Weighted-average shares used in computing net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted
Weighted-average shares used in computing net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted
−Removed: (1) Includes related party amount of $ 13,537 for the three months ended September 30, 2024 and $ 33,967 for the period from February 6, 2024 (inception) to September 30, 2024
−Removed: (2) Includes related party amount of $ 71 for the three months ended September 30, 2024 and $ 1,339 for the period from February 6, 2024 (inception) to September 30, 2024
−Removed: (3) Includes related party amount of $ 504 for the three months ended September 30, 2024 and $ 1,468 for the period from February 6, 2024 (inception) to September 30, 2024
−Removed: accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: THERAPEUTICS, INC.
+Added: (1) Includes related party amounts of $ 2,122 for the three months ended March 31, 2025 and $ 5,051 for the period from February 6, 2024 (inception) to March 31, 2024
+Added: (2) Includes related party amounts of $ 110 for the three months ended March 31, 2025 and $ 848 for the period from February 6, 2024 (inception) to March 31, 2024
+Added: (3) Includes related party amounts of nil for the three months ended March 31, 2025 and $ 214 for the period from February 6, 2024 (inception) to March 31, 2024
+Added: The accompanying notes are an integral part of
+Added: these condensed consolidated financial statements.
+Added: ORUKA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(In thousands, except share data)
−Removed: Convertible Preferred Stock
+Added: Preferred Stock
+Added: Accumulated Other Comprehensive
+Added: Stockholders’
+Added: Balances as of December 31, 2024
+Added: Stock-based compensation expense
+Added: Net change in unrealized gains (losses) on marketable securities
+Added: Balances as of March 31, 2025
+Added: $ ( 104,723 )
Convertible Preferred Stock
+Added: Series B Non-Voting
Convertible Preferred Stock
+Added: Accumulated Other Comprehensive
Stockholders ’
−Removed: of February 6, 2024 (inception)
−Removed: of common stock
+Added: Balances as of February 6, 2024 (Inception)
+Added: Issuance of common stock
Issuance of Series A convertible preferred stock, net of issuance costs of $69
−Removed: Stock-based compensation
+Added: Stock-based compensation expense
Balances as of March 31, 2024
−Removed: Stock-based compensation
−Removed: Balances as of June 30,
−Removed: Exchange of Series A convertible
−Removed: preferred stock for Series B non-voting convertible preferred stock upon the closing of the reverse recapitalization
−Removed: Conversion of convertible
−Removed: notes (including accrued interest) into common stock upon the closing of the reverse recapitalization
−Removed: Issuance of common stock
−Removed: and pre-funded warrants in the Pre-Closing Financing,
−Removed: Issuance costs of Pre-Closing
−Removed: Financing and reverse recapitalization
−Removed: Issuance of common stock
−Removed: to former stockholders of ARCA biopharma, Inc.
−Removed: in connection with the closing of the reverse recapitalization
−Removed: Issuance of common stock,
−Removed: Series A non-voting convertible preferred stock, and pre-funded warrants in connection with the PIPE Financing
−Removed: Issuance cost of PIPE Financing
−Removed: Stock-based compensation
−Removed: as of September 30, 2024
−Removed: accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: THERAPEUTICS, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
+Added: The accompanying notes are an integral part of
+Added: these condensed consolidated financial statements.
+Added: ORUKA THERAPEUTICS, INC.
+Added: CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Inception) to
−Removed: September 30,
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
−Removed: Depreciation expense
Stock-based compensation expense
+Added: Net accretion of premiums and discounts on marketable securities
Non-cash interest expense
Non-cash lease expense
+Added: Depreciation expense
Changes in operating assets and liabilities:
+Added: Subscription receivable
Prepaid expenses and other current assets
4 unchanged sentences
Related party accounts payable and other current liabilities
+Added: Accrued interest payable, related party
Net cash used in operating activities
1 unchanged sentence
Purchases of property and equipment
−Removed: Net cash used in investing activities
+Added: Purchases of marketable securities
+Added: Proceeds from maturities of marketable securities
+Added: Net cash provided by investing activities
Cash flows from financing activities:
Proceeds from issuance of Pre-Merger Oruka Series A Preferred Stock, net of issuance costs paid
−Removed: Proceeds from issuance of notes payable to related parties, net of issuance costs paid
−Removed: Proceeds from the Pre-Closing Financing, net
−Removed: Proceeds from the PIPE Financing, net
−Removed: Cash acquired in connection with the reverse recapitalization
+Added: Proceeds from issuance of notes payable to related party, net of issuance costs paid
Net cash provided by financing activities
Net increase in cash and cash equivalents
−Removed: Cash at beginning of period
+Added: Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
−Removed: Supplemental disclosure of non-cash operating and financing activities:
−Removed: Operating lease liability arising from obtaining operating right-of-use asset
−Removed: Assets acquired in connection with the reverse recapitalization
−Removed: Other liabilities assumed in connection with the reverse recapitalization
−Removed: Pre-Closing Financing and reverse recapitalization issuance costs included in accounts payable
−Removed: PIPE Financing issuance costs included in accounts payable
−Removed: PIPE Financing issuance costs included in accrued expenses and other current liabilities
−Removed: Non-cash accrued interest on convertible note converted to common stock
−Removed: Non-cash exchange of Pre-Merger Oruka Series A Preferred Stock for Company Series B Convertible Preferred Stock
−Removed: accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: THERAPEUTICS, INC.
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Nature of the Business and Basis of Presentation
−Removed: and Basis of Presentation
−Removed: Oruka Therapeutics, Inc., together with its subsidiaries (collectively,
−Removed: the “Company”), formerly known as ARCA biopharma, Inc.
−Removed: (“ARCA”), is an early-stage biotechnology company that
−Removed: is the result of the reverse recapitalization discussed below.
−Removed: Prior to the reverse recapitalization, the private company Oruka Therapeutics,
−Removed: (“Pre-Merger Oruka”) was established and incorporated under the laws of the state of Delaware on February 6, 2024
−Removed: (referred to in the Notes as the inception of the Company).
−Removed: The Company is headquartered in Menlo Park, California.
−Removed: The Company is focused
−Removed: on developing biologics to optimize the treatment of inflammatory skin diseases.
−Removed: These condensed consolidated financial statements reflect, in the opinion
−Removed: of management, all adjustments of a normal and recurring nature that are necessary for a fair statement of the Company’s financial
−Removed: position as of September 30, 2024, and its results of operations for the three months ended September 30, 2024 and from February 6, 2024
−Removed: (inception) to September 30, 2024, and cash flows for the period from February 6, 2024 (inception) to September 30, 2024.
−Removed: The condensed
−Removed: balance sheet as of February 6, 2024, included in the condensed consolidated balance sheets was derived from the Company’s audited
−Removed: financial statements.
−Removed: The condensed consolidated financial statements and accompanying notes are prepared in accordance with United States
−Removed: (“U.S.”) generally accepted accounting principles (“GAAP”) for interim financial reporting and the rules and regulations
−Removed: Securities and Exchange Commission (the “SEC”) and therefore do not include all information and disclosures normally
−Removed: included in the annual consolidated financial statements.
−Removed: The results for the three months ended September
−Removed: 30, 2024 and the period from February 6, 2024 (inception) to September 30, 2024 are not necessarily indicative of results expected for
−Removed: the full fiscal year or any subsequent interim period.
−Removed: The condensed consolidated financial statements include the financial statements
−Removed: of its wholly-owned subsidiaries.
−Removed: All significant intercompany balances and transactions have been eliminated in consolidation.
−Removed: Recapitalization and Pre-Closing Financing
−Removed: On August 29, 2024, the Company consummated the
−Removed: previously announced business combination (“Closing”) pursuant to that certain Agreement and Plan of Merger and Reorganization,
−Removed: dated April 3, 2024 (the “Merger Agreement”), by and among ARCA, Atlas Merger Sub Corp, a wholly owned subsidiary of ARCA
−Removed: (“First Merger Sub”), Atlas Merger Sub II, LLC, a wholly owned subsidiary of ARCA (“Second Merger Sub”) and Pre-Merger
−Removed: Oruka, pursuant to which, among other matters, Pre-Merger Oruka merged with and into First Merger Sub, with Pre-Merger Oruka continuing
−Removed: as a wholly owned subsidiary of ARCA and the surviving corporation of the merger (“First Merger”) and following that, Pre-Merger
−Removed: Oruka then merged with and into Second Merger Sub, with Second Merger Sub being the surviving entity of the second merger (the “Second
−Removed: Merger” and together with the First Merger, the “Merger”).
−Removed: Following consummation of the Merger, the Company effected
−Removed: a 1-for-12 reverse stock split (the “Reverse Stock Split”) of the common stock, par value $ 0.001 per share, of the Company
−Removed: (“Company Common Stock”), which became effective on September 3, 2024.
−Removed: The Company Common Stock commenced trading on a post-Reverse
−Removed: Stock Split, post-Merger basis at the opening of trading on September 3, 2024.
−Removed: Second Merger Sub changed its corporate name to “Oruka
−Removed: Therapeutics Operating Company, LLC” and ARCA changed its name to “Oruka Therapeutics, Inc.” The Company is led by the
−Removed: Pre-Merger Oruka management team and remains focused on developing biologics to optimize the treatment of inflammatory skin diseases.
−Removed: Immediately prior to the execution and delivery of the Merger Agreement
−Removed: on April 3, 2024, certain new and existing investors of Pre-Merger Oruka entered into a subscription agreement with Pre-Merger Oruka (the
−Removed: “Subscription Agreement”), pursuant to which, and on the terms and subject to the conditions of which, immediately prior to
−Removed: the Closing, those investors purchased shares of common stock of Pre-Merger Oruka (“Pre-Merger Oruka Common Stock”) and Pre-Merger
−Removed: Oruka pre-funded warrants for gross proceeds of approximately $ 275.0 million (which includes $ 25.0 million of proceeds previously received
−Removed: from the issuance of the Convertible Note (as defined in Note 6) and accrued interest on such note which converted to shares of Pre-Merger
−Removed: Oruka Common Stock) (the “Pre-Closing Financing”).
−Removed: The Company incurred transaction costs of $ 20.5 million which was recorded
−Removed: as a reduction to additional paid-in capital in the unaudited condensed consolidated financial statements.
−Removed: At the Closing, the shares
−Removed: of Pre-Merger Oruka Common Stock and Pre-Merger Oruka pre-funded warrants issued pursuant to the Subscription Agreement were converted
−Removed: into shares of Company Common Stock and pre-funded warrants of Company Common Stock in accordance with the Exchange Ratio (defined below).
−Removed: In accordance with an Exchange Ratio determined
−Removed: by terms of the Merger Agreement and upon the effective time of the First Merger (the “First Effective Time”), (i) each then-issued
−Removed: and outstanding share of Pre-Merger Oruka Common Stock including outstanding and unvested Pre-Merger Oruka restricted stock and shares
−Removed: of Pre-Merger Oruka Common Stock issued in connection with the Subscription Agreement, were converted into the right to receive a number
−Removed: of shares of Company Common Stock, equal to the Exchange Ratio of 6.8569 shares of Company Common Stock, which were subject to the same
−Removed: vesting provisions as those immediately prior to the Merger, (ii) each share of Pre-Merger Oruka Series A convertible preferred stock,
−Removed: par value $ 0.0001 (“Pre-Merger Oruka Series A Preferred Stock”), outstanding immediately prior to the First Effective Time
−Removed: was converted into the right to receive a number of shares of ARCA Series B non-voting convertible preferred stock, par value $ 0.001 per
−Removed: share (“Company Series B Preferred Stock”), which are convertible into shares of Company Common Stock, at a conversion ratio
−Removed: of approximately 83:3332:1 (iii) each outstanding option to purchase Pre-Merger Oruka Common Stock was converted into an option to purchase
−Removed: shares of Company Common Stock, (iv) each outstanding warrant to purchase shares of Pre-Merger Oruka Common Stock was converted into a
−Removed: warrant to purchase shares of Company Common Stock, and (v) each share of Company Common Stock issued and outstanding at the First Effective
−Removed: Time remain issued and outstanding in accordance with its terms and such shares.
−Removed: Subsequent to the close of the merger, the common stock
−Removed: shares were then, subject to the reverse stock split of 1-for-12 effected on September 3, 2024.
−Removed: Net loss per share for periods prior to
−Removed: the close of the reverse recapitalization has been revised to reflect the exchange ratio.
−Removed: After applying the exchange ratio and the reverse
−Removed: stock split, net loss per share for the periods from February 6, 2024 (inception) to March 31, 2024 and for three months ended June 30,
−Removed: 2024 and from February 6, 2024 (inception) to June 30, 2024 are $( 2.21 ), $( 6.96 ), and $( 9.17 ), respectively.
−Removed: As part of the Pre-Closing Financing and the Closing,
−Removed: investors in the Pre-Closing Financing received 22,784,139 shares of Company Common Stock in exchange for 39,873,706 shares of Pre-Merger
−Removed: Oruka Common Stock (which includes the issuance of 2,722,207 shares of Company Common Stock in exchange for 4,764,032 shares of Pre-Merger
−Removed: Oruka Common Stock on the conversion of Convertible Note along with the accrued interest through the conversion date) and 5,522,207 Company
−Removed: pre-funded warrants in exchange for 9,664,208 Pre-Merger pre-funded warrants.
−Removed: The Merger was accounted for as a reverse recapitalization
−Removed: in accordance with U.S.
−Removed: Under this method of accounting, Pre-Merger Oruka was deemed to be the accounting acquirer for financial
−Removed: reporting purposes.
−Removed: This determination was primarily based on the fact that, immediately following the Merger:
−Removed: (i) Pre-Merger Oruka stockholders
−Removed: own a substantial majority of the voting rights in the combined company;
−Removed: (ii) Pre-Merger Oruka’s largest stockholders retain the
−Removed: largest interest in the combined company;
−Removed: (iii) Pre-Merger Oruka designated a majority of the initial members of the board of directors
−Removed: of the combined company;
−Removed: and (iv) Pre-Merger Oruka’s executive management team became the management team of the combined company.
+Added: Supplemental disclosures of non-cash operating and financing activities:
+Added: Deferred offering costs in accrued expenses and other current liabilities
+Added: The accompanying notes are an integral part of
+Added: these condensed consolidated financial statements.
+Added: ORUKA THERAPEUTICS, INC.
+Added: NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: of the Business and Basis of Presentation
+Added: Background and Basis of Presentation
+Added: Oruka Therapeutics, Inc.,
+Added: together with its subsidiaries (collectively, the “Company”), formerly known as ARCA biopharma, Inc.
+Added: is a clinical-stage biopharmaceutical company that is the result of the reverse recapitalization discussed below.
+Added: Prior to the reverse
+Added: recapitalization, the private company Oruka Therapeutics, Inc.
+Added: (“Pre-Merger Oruka”) was established and incorporated under
+Added: the laws of the state of Delaware on February 6, 2024 (referred to in the Notes as the inception of the Company).
+Added: The Company is
+Added: headquartered in Menlo Park, California.
+Added: The Company is led by the Pre-Merger Oruka management team and is focused on developing biologics
+Added: for psoriasis and other inflammatory and immunology indications.
+Added: The condensed consolidated
+Added: financial statements and accompanying notes are prepared in accordance with United States (“U.S.”) generally accepted accounting
+Added: principles (“GAAP”) for interim financial reporting and the rules and regulations of the U.S.
+Added: Securities and Exchange Commission
+Added: (the “SEC”) and therefore do not include all information and disclosures normally included in the annual consolidated financial
+Added: The accompanying condensed consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries.
+Added: Intercompany balances and transactions have been eliminated in consolidation.
+Added: Certain information and footnote
+Added: disclosures normally included in the financial statements prepared in accordance with U.S.
+Added: GAAP have been condensed or omitted pursuant
+Added: to such rules and regulations.
+Added: Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited
+Added: financial statements and the related notes thereto for the period ended December 31, 2024 included in the Company’s Annual Report
+Added: on Form 10-K filed with the SEC on March 6, 2025 (the “Annual Report”).
+Added: The information as of December 31, 2024, included
+Added: in the condensed consolidated balance sheets was derived from the Company’s audited financial statements.
+Added: These unaudited interim
+Added: condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial
+Added: statements, and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for a
+Added: fair statement of the Company’s condensed consolidated financial statements.
+Added: The results for the three
+Added: months ended March 31, 2025 are not necessarily indicative of results that may be expected for the year ending December 31, 2025 or for
+Added: any other interim period or for any other future year.
+Added: Reverse Recapitalization, Pre-Closing Financing, and Reverse Stock Split
+Added: On August 29, 2024 (the “Closing”),
+Added: the Company completed the acquisition (the “Merger”) of Pre-Merger Oruka pursuant to an Agreement and Plan of Merger and Reorganization,
+Added: dated as of April 3, 2024 (the “Merger Agreement”).
+Added: Following the transactions contemplated by the Merger Agreement, on August
+Added: 29, 2024, the Company changed its name from “ARCA biopharma, Inc.” to “Oruka Therapeutics, Inc.” and the Company
+Added: effected a 1-for-12 reverse stock split (the “Reverse Stock Split”) of the common stock, par value $ 0.001 per share, of the
+Added: Company (“Company Common Stock”), which became effective on September 3, 2024.
+Added: All references to common stock, options to
+Added: purchase common stock, outstanding common stock warrants, common stock share data, per share data, and related information contained in
+Added: the condensed consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for
+Added: all periods presented, unless otherwise specifically indicated or the context otherwise requires.
+Added: Immediately prior to the execution and delivery
+Added: of the Merger Agreement, certain new and existing investors of Pre-Merger Oruka entered into a subscription agreement with Pre-Merger
+Added: Oruka (that was subsequently amended and restated in July 2024, the “Subscription Agreement”), pursuant to which, and on the
+Added: terms and subject to the conditions of which, immediately prior to the Closing, those investors purchased shares of common stock of Pre-Merger
+Added: Oruka (“Pre-Merger Oruka Common Stock”) and Pre-Merger Oruka pre-funded warrants for gross proceeds of approximately $ 275.0
+Added: million (which includes $ 25.0 million of proceeds previously received from the issuance of the Convertible Note (as defined in Note 6)
+Added: and accrued interest on such note which converted to shares of Pre-Merger Oruka Common Stock) (the “Pre-Closing Financing”).
+Added: The Company incurred transaction costs of $ 20.5 million which were recorded as a reduction to additional paid-in capital in the condensed
+Added: consolidated financial statements.
+Added: In connection with the Closing, the shares of Pre-Merger Oruka Common
+Added: Stock were converted into shares of Company Common Stock and pre-funded warrants of Company Common Stock in accordance with the Exchange
+Added: Ratio (as defined below and determined by the terms of the Merger Agreement).
+Added: Moreover, as part of the Closing, (i) then-issued and
+Added: outstanding share of Pre-Merger Oruka Common Stock (including outstanding and unvested Pre-Merger Oruka restricted stock and shares of
+Added: Pre-Merger Oruka Common Stock issued in connection with the Subscription Agreement) were converted into the right to receive a number
+Added: of shares of Company Common Stock, equal to the exchange ratio of 6.8569 shares of Company Common Stock (the “Exchange Ratio”),
+Added: which were subject to the same vesting provisions as those immediately prior to the Merger;
+Added: (ii) each share of Pre-Merger Oruka Series
+Added: A convertible preferred stock, par value $ 0.0001 (“Pre-Merger Oruka Series A Preferred Stock”) was converted into the right
+Added: to receive a number of shares of ARCA Series B non-voting convertible preferred stock, par value $ 0.001 per share (“Company Series
+Added: B Preferred Stock”), which are convertible into shares of Company Common Stock at a conversion ratio of approximately 83.3332:1
+Added: after the Reverse Stock Split, (iii) each outstanding option to purchase Pre-Merger Oruka Common Stock was converted into an option to
+Added: purchase shares of Company Common Stock, and (iv) each outstanding warrant to purchase shares of Pre-Merger Oruka Common Stock was converted
+Added: into a warrant to purchase shares of Company Common Stock.
+Added: The Merger was accounted
+Added: for as a reverse recapitalization in accordance with U.S.
+Added: Under this method of accounting, Pre-Merger Oruka was deemed to be the
+Added: accounting acquirer for financial reporting purposes.
+Added: This determination was primarily based on the fact that, immediately following the
+Added: (i) Pre-Merger Oruka stockholders own a substantial majority of the voting rights in the combined company;
+Added: (ii) Pre-Merger Oruka’s
+Added: largest stockholders retain the largest interest in the combined company;
+Added: (iii) Pre-Merger Oruka designated a majority of the initial
+Added: members of the board of directors of the combined company;
+Added: and (iv) Pre-Merger Oruka’s executive management team became the management
+Added: team of the combined company.
Accordingly, for accounting purposes:
−Removed: (i) the Merger was treated as the equivalent of Pre-Merger Oruka issuing stock to acquire the net
−Removed: assets of ARCA, and (ii) the reported historical operating results of the combined company prior to the Merger are those of Pre-Merger
−Removed: Additional information regarding the Merger is included in Note 3.
−Removed: Reverse Stock Split
−Removed: On September 3, 2024, the Company effected the
−Removed: Reverse Stock Split, a 1-for-12 reverse stock split of Company Common Stock.
−Removed: The par value per share and the number of authorized shares
−Removed: were not adjusted as a result of the Reverse Stock Split.
−Removed: The shares of Company Common Stock underlying outstanding stock options, common
−Removed: stock warrants and other equity instruments were proportionately reduced and the respective exercise prices, if applicable, were proportionately
−Removed: increased in accordance with the terms of the agreements governing such securities.
−Removed: All references to common stock, options to purchase
−Removed: common stock, outstanding common stock warrants, common stock share data, per share data, and related information contained in the condensed
−Removed: consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods
−Removed: presented, unless otherwise specifically indicated or the context otherwise requires.
+Added: (a) the Merger was treated as the equivalent of Pre-Merger Oruka issuing
+Added: stock to acquire the net assets of ARCA, and (b) the reported historical operating results of the combined company prior to the Merger
+Added: are those of Pre-Merger Oruka.
+Added: As part of the reverse recapitalization, the Company acquired a cash balance of $ 4.94 million from ARCA.
PIPE Financing
−Removed: On September 11, 2024, the Company entered into
−Removed: a Securities Purchase Agreement for a private placement (the “PIPE Financing”) with certain institutional and accredited investors.
+Added: On September 11, 2024, the
+Added: Company entered into a Securities Purchase Agreement for a private placement (the “PIPE Financing”) with certain institutional
+Added: and accredited investors.
The closing of the PIPE Financing occurred on September 13, 2024.
−Removed: Pursuant to the Securities Purchase Agreement,
−Removed: the investors purchased an aggregate of 5,600,000 shares of Company Common Stock at a purchase price of $ 23.00 per share, an aggregate
−Removed: of 2,439 shares of the Company’s Series A non-voting convertible preferred stock, par value $ 0.001 per share (“Company Series
−Removed: A Preferred Stock”), at a purchase price of $ 23,000.00 per share (each Company Series A Preferred Stock is convertible into 1,000
−Removed: shares of Company Common Stock), and pre-funded warrants to purchase an aggregate of 680,000 shares of Company Common Stock at a purchase
−Removed: price of $ 22.999 per pre-funded warrant, for aggregate net proceeds of approximately $ 188.7 million (net of issuance costs of $ 11.8 million).
−Removed: and Going Concern
−Removed: its inception, the Company has devoted substantially all of its resources to advancing the development of its portfolio of programs,
−Removed: organizing and staffing the Company, business planning, raising capital, and providing general and administrative support for these operations.
−Removed: Current and future programs will require significant research and development efforts, including preclinical and clinical trials, and
−Removed: regulatory approvals to commercialization.
−Removed: Until such time as the Company can generate significant revenue from product sales, if ever,
−Removed: the Company expects to finance its operating activities through a combination of equity offerings and debt financings.
−Removed: The Company has not generated any revenue from
−Removed: product sales or other sources and has incurred significant operating losses and negative cash flows from operations since inception.
−Removed: The Company has incurred a net loss of $ 28.6 million for the three months ended September 30, 2024 and $ 57.9 million during the
−Removed: period from February 6, 2024 (inception) to September 30, 2024.
−Removed: For the period from February 6, 2024 (inception) to September 30,
−Removed: 2024, the Company used net cash of $ 39.0 million for its operating activities.
−Removed: As of September 30, 2024, the Company had cash
−Removed: and cash equivalents of $ 410.9 million.
−Removed: The Company’s management expects that the existing cash and cash equivalents will be sufficient
−Removed: to fund the Company’s operating plans for at least twelve months from the date these condensed consolidated financial statements
−Removed: The Company expects that its research and development and general and administrative costs will continue to increase significantly,
−Removed: including in connection with conducting future pre-clinical activities and clinical trials and manufacturing for its existing product
−Removed: candidates and any future product candidates to support commercialization and providing general and administrative support for its operations,
−Removed: including the costs associated with operating as a public company.
−Removed: The Company’s ability to access capital when needed is not assured
−Removed: and, if capital is not available to the Company when, and in the amounts needed, the Company may be required to significantly curtail,
−Removed: delay or discontinue one or more of its research or development programs or the commercialization of any product candidate, or be unable
−Removed: to expand its operations or otherwise capitalize on the Company’s business opportunities, as desired, which could materially harm
−Removed: the Company’s business, financial condition and results of operations.
+Added: Pursuant to the Securities
+Added: Purchase Agreement, the investors purchased an aggregate of 5,600,000 shares of Company Common Stock at a purchase price of $ 23.00 per
+Added: share, an aggregate of 2,439 shares of the Company’s Series A non-voting convertible preferred stock, par value $ 0.001 per share
+Added: (“Company Series A Preferred Stock”), at a purchase price of $ 23,000.00 per share (each share of Company Series A Preferred
+Added: Stock was convertible into 1,000 shares of Company Common Stock), and pre-funded warrants to purchase an aggregate of 680,000 shares of
+Added: Company Common Stock at a purchase price of $ 22.999 per pre-funded warrant, for aggregate net proceeds of approximately $ 188.7 million
+Added: (net of issuance costs of $ 11.9 million).
+Added: In November 2024, the 2,439 shares of the Company Series A Preferred Stock were converted
+Added: to 2,439,000 shares of Company Common Stock.
+Added: Liquidity and Going Concern
+Added: Since its inception, the
+Added: Company has devoted substantially all of its resources to advancing the development of its portfolio of programs, organizing and staffing
+Added: the Company, business planning, raising capital, and providing general and administrative support for these operations.
+Added: Current and future
+Added: programs will require significant research and development efforts, including preclinical and clinical trials, and regulatory approvals
+Added: to commercialization.
+Added: Until such time as the Company can generate significant revenue from product sales, if ever, the Company expects
+Added: it will need additional financing to fund its operating activities.
+Added: The Company has not generated
+Added: any revenue from product sales or other sources and has incurred significant operating losses and negative cash flows from operations
+Added: since inception.
+Added: For the three months ended March 31, 2025, the Company incurred a net loss of $ 21.0 million and used net cash of $ 20.9
+Added: million for its operating activities.
+Added: As of March 31, 2025, the
+Added: Company had cash, cash equivalents, and marketable securities of $ 373.0 million.
+Added: The Company’s management expects that the existing
+Added: cash, cash equivalents, and marketable securities will be sufficient to fund the Company’s operating plans for at least twelve months
+Added: from the date these condensed consolidated financial statements were issued.
+Added: The Company expects that its research and development and
+Added: general and administrative costs will continue to increase significantly, including in connection with conducting pre-clinical activities
+Added: and clinical trials and manufacturing for its existing product candidates and any future product candidates to support commercialization
+Added: and providing general and administrative support for its operations, including the costs associated with operating as a public company.
+Added: The Company’s ability to access capital when needed is not assured and, if capital is not available to the Company when, and in
+Added: the amounts needed, the Company may be required to significantly curtail, delay, or discontinue one or more of its research or development
+Added: programs or the commercialization of any product candidate, or be unable to expand its operations or otherwise capitalize on the Company’s
+Added: business opportunities, as desired, which could materially harm the Company’s business, financial condition and results of operations.
+Added: Summary of Significant Accounting
+Added: The Company’s significant accounting policies are detailed in
+Added: the Notes titled “1.
+Added: Nature of the Business and Basis of Presentation” and “2.
Summary of Significant Accounting Policies”
−Removed: The preparation of the Company’s condensed consolidated financial
−Removed: statements in conformity with U.S.
−Removed: GAAP requires management to make estimates, assumptions, and judgments that affect the reported
−Removed: amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the condensed consolidated financial statements
−Removed: and the reported amounts of income and expenses during the reporting periods.
−Removed: Significant estimates and assumptions reflected within these
−Removed: condensed consolidated financial statements include but are not limited to research and development expenses and related prepaid or accrued
−Removed: costs and the valuation of stock-based compensation awards and related expenses.
−Removed: The Company bases its estimates on known trends and other
−Removed: market-specific or other relevant factors that it believes to be reasonable under the circumstances.
−Removed: On an ongoing basis, management evaluates
−Removed: its estimates, as there are changes in circumstances, facts, and experience.
−Removed: Actual results could differ materially from those estimates
−Removed: or assumptions.
−Removed: Concentrations
−Removed: of Credit Risk and Other Risks and Uncertainties
−Removed: Company’s cash and cash equivalents are maintained with financial institutions in the United States of America.
−Removed: Cash balances
−Removed: are held at financial institutions and account balances may exceed federally insured limits.
−Removed: To date, the Company has not experienced
−Removed: any losses on its cash and cash equivalents and periodically evaluates the creditworthiness of its financial institutions.
−Removed: The Company manages credit risk associated with its investment portfolio
−Removed: through its investment policy, which limits investments to high-quality issuers and limits the amount of its portfolio that can be invested
−Removed: in a single issuer.
−Removed: The Company is dependent on third-party organizations
−Removed: to research, develop, manufacture, and process its product candidates for its development programs, including its two most advanced programs,
−Removed: ORKA-001 and ORKA-002.
−Removed: The Company expects to continue to be dependent on a small number of manufacturers to supply it with its requirements
−Removed: for all products.
−Removed: The Company’s research and development programs could be adversely affected by a significant interruption in the
−Removed: supply of the necessary materials.
−Removed: A significant amount of the Company’s research and development activities are performed under
−Removed: its agreements with Paragon Therapeutics, Inc.
−Removed: (“Paragon”) (see Note 10).
−Removed: and Cash Equivalents
−Removed: Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to
−Removed: be cash equivalents.
−Removed: The cash equivalents were comprised of investments in money market funds.
−Removed: Issuance Costs
−Removed: Debt issuance costs incurred in connection with
−Removed: the Convertible Note (see Note 6) are recorded as a reduction of the carrying value of the notes payable liability on the Company’s
−Removed: balance sheet and are amortized to interest expense over the term of the loan using the effective interest method.
−Removed: Subscription Receivable
−Removed: Company accounts for any notes received in exchange for common stock as a subscription receivable, provided the note underlying the receivable
−Removed: is paid prior to the date the financial statement is available to be issued.
−Removed: Value Measurements
−Removed: assets and liabilities are carried at fair value under U.S.
−Removed: Fair value is defined as the exchange price that would be
−Removed: received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability
−Removed: in an orderly transaction between market participants on the measurement date.
−Removed: Valuation techniques used to measure fair value must maximize
−Removed: the use of observable inputs and minimize the use of unobservable inputs.
−Removed: Financial assets and liabilities carried at fair value are
−Removed: to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered
−Removed: observable and the last is considered unobservable:
−Removed: — Quoted prices in active markets that are identical assets or liabilities.
−Removed: Level 2 — Observable
−Removed: inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices
−Removed: in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated
−Removed: by observable market data.
−Removed: Level 3 — Unobservable
−Removed: inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities,
−Removed: including pricing models, discounted cash flow methodologies, and similar techniques.
−Removed: Company’s cash equivalents are carried at fair value, determined according to the fair value hierarchy described above (see Note
−Removed: The carrying values of the Company’s prepaid expenses and other current assets, accounts payable and accrued expenses and other
−Removed: current liabilities approximate their fair values due to their relatively short maturity period.
−Removed: and Equipment
−Removed: and equipment are stated at cost less accumulated depreciation.
−Removed: Depreciation expense is recognized using the straight-line method over
−Removed: the estimated useful life of each asset as follows:
−Removed: Estimated Useful Life
−Removed: Furniture and fixtures
−Removed: Computer and office equipment
−Removed: Classification
−Removed: of Convertible Preferred Stock
−Removed: Prior to the reverse recapitalization, the Company
−Removed: had classified its Pre-Merger Oruka Series A Preferred Stock outside of stockholders’ equity (deficit) on the Company’s condensed
−Removed: consolidated balance sheet because the holders of such stock have certain liquidation rights in the event of a deemed liquidation event
−Removed: that, in certain situations, is not solely within the control of the Company and would require the redemption of the then-outstanding
−Removed: convertible preferred stock.
−Removed: Upon the closing of the Merger, the Company converted
−Removed: its Pre-Merger Oruka Series A Preferred Stock to Company Series B Preferred Stock and has classified the Company Series B Preferred Stock
−Removed: within stockholders’ equity (deficit) on its condensed consolidated balance sheet because the Company Series B Preferred Stock is
−Removed: not redeemable or puttable to the Company by the holder under any circumstances.
−Removed: In connection with the PIPE Financing (see Note
−Removed: 1) the Company issued Company Series A Preferred Stock, and has classified the Company Series A Preferred Stock outside of stockholders’
−Removed: equity (deficit) on the Company’s condensed consolidated balance sheet because the holders of such stock have certain rights (see
−Removed: Note 7) that, in certain situations, is not solely within the control of the Company and would require the redemption of the then-outstanding
−Removed: convertible preferred stock.
−Removed: to Related Party
−Removed: The Company accounted for the Convertible Note
−Removed: (as defined in Note 6) at amortized cost.
−Removed: The Company considered if optional conversion features are required to be bifurcated and separately
−Removed: accounted for as a derivative.
−Removed: Costs related to the issuance of the Convertible Note were recorded as a debt discount, amortized over
−Removed: the term of the Convertible Note (see Note 6) and were accounted as interest expense in other income (expenses) within the condensed
−Removed: consolidated statements of operations and comprehensive loss using the effective interest method.
−Removed: At the effective time of the Merger,
−Removed: shares of Pre-Merger Oruka Common Stock issued pursuant to the conversion of the Convertible Note (including accrued interest) automatically
−Removed: converted into shares of Company Common Stock (see Note 1).
−Removed: and Development Contract Costs Accruals
−Removed: The Company records the costs associated with
−Removed: research studies and manufacturing development as incurred.
−Removed: These costs are a significant component of the Company’s research and
−Removed: development expenses, with a substantial portion of the Company’s ongoing research and development activities conducted by third-party
−Removed: service providers, including contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”),
−Removed: and the Company’s related-party Paragon (see Note 10).
−Removed: The Company accrues for expenses resulting from
−Removed: obligations under its two antibody discovery and option agreements (the “Option Agreements”) (see Note 10), by and among Paragon,
−Removed: Paruka Holding LLC (“Paruka”), an entity formed by Paragon as a vehicle to hold equity in the Company, and the Company as
−Removed: well as agreements with CROs, CMOs, and other outside service providers for which payment flows do not match the periods over which materials
−Removed: or services are provided to the Company.
−Removed: Accruals are recorded based on estimates of services received and efforts expended pursuant to
−Removed: agreements established with Paragon, CROs, CMOs, and other outside service providers.
−Removed: These estimates are typically based on contracted
−Removed: amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers
−Removed: as to the progress or stage of completion of the services.
−Removed: The Company makes significant judgments and estimates in determining the accrual
−Removed: balance in each reporting period.
−Removed: If advance payments are made to Paragon, a CRO, CMO, or outside service provider, the payments will
−Removed: be recorded as a prepaid asset which will be expensed as the contracted services are performed.
−Removed: Changes in these estimates that result
−Removed: in material changes to the Company’s accruals could materially affect the Company’s results of operations.
−Removed: As of September
−Removed: 30, 2024, the Company has not experienced any material deviations between accrued and actual research and development expenses.
−Removed: the lease commencement date, when control of the underlying asset is transferred from the lessor to the Company, the Company classifies
−Removed: a lease as either an operating or finance lease and recognizes a right-of-use (“ROU”) asset and a current and non-current
−Removed: lease liability, as applicable, in the balance sheet if the lease has a term greater than one year .
−Removed: Lease terms may include options to
−Removed: extend or terminate the lease when it is reasonably certain that the Company will exercise its option.
−Removed: the lease commencement date, operating lease liabilities and their corresponding ROU assets are recorded at the present value of future
−Removed: minimum lease payments over the expected remaining lease term.
−Removed: The Company determines the present value of lease payments using the implicit
−Removed: rate, if it is readily determinable, or the risk-free discount rate for a period comparable with that of the lease term.
−Removed: For operating
−Removed: leases, lease expense for lease payments is recognized on a straight-line basis over the lease term.
−Removed: For finance leases, lease expense
−Removed: includes amortization expense of the ROU asset recognized on a straight-line basis over the lease term and interest expense recognized
−Removed: on the finance lease liability.
−Removed: In addition, certain adjustments to the ROU asset may be required for items such as lease prepayments,
−Removed: incentives received or initial direct costs.
−Removed: As of September 30, 2024, the Company has one operating lease and no finance leases.
−Removed: Company accounts for lease and non-lease components related to operating leases as a single lease component.
−Removed: The Company has elected
−Removed: that costs associated with leases having an initial term of 12 months or less are recognized in the condensed consolidated statement
−Removed: of operations and comprehensive loss on a straight-line basis over the lease term and are not recorded on its condensed consolidated
−Removed: balance sheets.
−Removed: Variable lease expense is recognized as incurred and consists primarily of real estate taxes, utilities, and other office
−Removed: space related expenses.
−Removed: Company operates and manages its business as a single segment for the purposes of assessing performance and making operating decisions.
−Removed: The Company’s chief executive officer, who is the chief operating decision maker (the “CODM”), reviews the Company’s
−Removed: financial information on an aggregated basis for purposes of evaluating financial performance and allocating resources.
−Removed: and Development Costs
−Removed: Research and development costs are expensed as
−Removed: Research and development costs include salaries and bonuses, stock-based compensation, employee benefits, and external costs
−Removed: of vendors and consultants engaged to conduct research and development activities, as well as allocated human resource costs, information
−Removed: technology costs, and facility-related costs, including rent, maintenance, utilities, and depreciation.
−Removed: Nonrefundable
−Removed: advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid
−Removed: expenses on the accompanying condensed consolidated balance sheet.
−Removed: The prepaid amounts are expensed as the related goods are delivered
−Removed: or the services are performed, or when it is no longer expected that the goods will be delivered, or the services rendered.
−Removed: If nonrefundable
−Removed: advance payments represent a one-time cost for obtaining goods or services, with anticipated benefits to be utilized within a year of
−Removed: period end, the payment is expensed immediately.
−Removed: and Administrative Expenses
−Removed: General and administrative expenses consist primarily
−Removed: of salaries and bonuses, stock-based compensation, employee benefits, finance and administration costs, patent and intellectual property
−Removed: costs, professional fees, as well as allocated human resource costs, information technology costs, and facility-related costs, including
−Removed: rent, maintenance, utilities and depreciation.
−Removed: and Contingencies
−Removed: The Company is subject to contingent liabilities,
−Removed: such as legal proceedings and claims, that arise in the ordinary course of business activities.
−Removed: The Company accrues for loss contingencies
−Removed: when losses become probable and are reasonably estimable.
−Removed: If the reasonable estimate of the loss is a range and no amount within the range
−Removed: is a better estimate, the minimum amount of the range is recorded as a liability on the balance sheet.
−Removed: The Company does not accrue for
−Removed: contingent losses that, in its judgment, are considered to be reasonably possible, but not probable;
−Removed: however, it discloses the range of
−Removed: reasonably possible losses.
−Removed: As of September 30, 2024, no liabilities were recorded for loss contingencies (see Note 11).
−Removed: Company measures all stock-based awards granted to employees, directors, and non-employees in the form of stock options to purchase shares
−Removed: of its common stock, based on the fair value of the awards on the date of grant using the Black-Scholes option-pricing model.
−Removed: measures restricted common stock awards (“RSAs”) using the difference, if any, between the purchase price per share of the
−Removed: award and the fair value of the Company’s common stock at the date of grant.
−Removed: Company grants stock options, restricted stock awards, and warrants that are subject to service or performance-based vesting conditions.
−Removed: Compensation expense for awards to employees and directors with service-based vesting conditions is recognized using the straight-line
−Removed: method over the requisite service period, which is generally the vesting period of the respective award.
−Removed: Compensation expense for awards
−Removed: to non-employees with service-based vesting conditions is recognized in the same manner as if the Company had paid cash in exchange for
−Removed: the goods or services, which is generally over the vesting period of the award.
−Removed: Forfeitures are accounted for as they occur.
−Removed: reporting date, the Company estimates the probability that specified performance criteria will be met and does not recognize compensation
−Removed: expense until it is probable that the performance-based vesting condition will be achieved.
−Removed: The Company has issued stock options, warrants,
−Removed: and RSAs with service-based and performance-based vesting conditions.
−Removed: Company recognizes the compensation expense for the option to purchase common stock under the Employee Stock Purchase Plan (“ESPP”),
−Removed: based on the fair value of the common stock estimated using the closing price of the Company’s common stock as reported on the
−Removed: date of offering, less the purchase discount percentage provided for in the plan.
−Removed: Company classifies stock-based compensation expense in its condensed consolidated statement of operations and comprehensive loss in the
−Removed: same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments
−Removed: are classified.
−Removed: Net Loss per Share Attributable to Stockholders
−Removed: Basic and diluted net loss attributable to stockholders
−Removed: per share is presented in conformity with the two-class method required for participating securities (Pre-Merger Oruka Series A Preferred
−Removed: Basic earnings per share is computed by dividing net income available to each class of shares by the weighted-average number of
−Removed: shares of common stock and participating securities outstanding during the period.
−Removed: Pre-funded warrants were included as the exercise price
−Removed: is negligible and these warrants are fully vested and exercisable.
−Removed: Company Series A Preferred Stock and Company Series B Preferred Stock
−Removed: share the same characteristics as Common Stock and have no substantive preference attributed to them and, accordingly, have been considered
−Removed: as classes of Common Stock in the computation of net loss per share regardless of their legal form.
−Removed: Net loss is allocated to common stock based on
−Removed: its proportional ownership on an as-converted basis.
−Removed: Net loss is not allocated to participating securities as they do not have an obligation
−Removed: to fund losses.
−Removed: The weighted-average number of shares outstanding of common stock reflects changes in ownership over the periods presented.
−Removed: See Note 7— Convertible Preferred Stock and Stockholders’ Equity.
−Removed: Diluted net loss per share is computed by dividing
−Removed: the net loss attributable to stockholders adjusted for income (expenses), net of tax, related to any diluted securities, by the weighted-average
−Removed: number of shares of common stock and potentially dilutive securities outstanding for the period.
−Removed: For purposes of this calculation, stock
−Removed: options to purchase common stock, employee warrants to purchase common stock, and unvested RSAs are considered potential dilutive common
−Removed: Company generated a net loss for the periods presented.
−Removed: Accordingly, basic and diluted net loss per share is the same because the inclusion
−Removed: of the potentially dilutive securities would be anti-dilutive.
−Removed: Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities
−Removed: for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax
−Removed: Deferred tax assets and liabilities are determined based on the differences between the financial statement basis and tax basis
−Removed: of assets and liabilities using enacted tax rates in effect for the years in which the differences are expected to reverse.
−Removed: in deferred tax assets and liabilities are recorded in the provision for income taxes.
−Removed: The Company assesses the likelihood that its deferred
−Removed: tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence,
−Removed: that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established
−Removed: through a charge to income tax expense.
−Removed: The potential for recovery of deferred tax assets is evaluated by estimating the future taxable
−Removed: profits expected and considering prudent and feasible tax planning strategies.
−Removed: Company accounts for uncertainty in income taxes recognized in the condensed consolidated financial statements by applying a two-step
−Removed: process to determine the amount of tax benefit to be recognized.
−Removed: First, the tax position must be evaluated to determine the likelihood
−Removed: that it will be sustained upon external examination by the taxing authorities.
−Removed: If the tax position is deemed more likely than not to
−Removed: be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the condensed consolidated financial
−Removed: The amount of the benefit that may be recognized is the largest amount that has a greater than 50 % likelihood of being realized
−Removed: upon ultimate settlement.
−Removed: The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits,
−Removed: that are considered appropriate as well as the related net interest and penalties.
−Removed: The Company had accrued no amounts for interest or
−Removed: penalties related to uncertain tax positions as of September 30, 2024.
−Removed: Issued Accounting Pronouncements
−Removed: In November 2023, the Financial Accounting
−Removed: Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting ( Topic 280 ) :
−Removed: Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which enhances the segment disclosure requirements
−Removed: for public entities on an annual and interim basis.
−Removed: Under this proposal, public entities will be required to disclose significant segment
−Removed: expenses that are regularly provided to the CODM and included within each reported measure of segment profit or loss.
−Removed: Additionally, current
−Removed: annual disclosures about a reportable segment’s profit or loss and assets will be required on an interim basis.
−Removed: Entities will also
−Removed: be required to disclose information about the CODM’s title and position at the Company along with an explanation of how the CODM
−Removed: uses the reported measures of segment profit or loss in their assessment of segment performance and deciding how to allocate resources.
−Removed: Finally, ASU 2023-07 requires all segment disclosures for public entities that have only a single reportable segment.
−Removed: The amendments
−Removed: in ASU 2023-07 are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years
−Removed: beginning after December 15, 2024.
−Removed: Early adoption is permitted.
−Removed: The Company is currently evaluating the impact of the adoption of
−Removed: this ASU on its consolidated financial statements.
−Removed: In December 2023, the FASB issued ASU 2023-09,
−Removed: Income Taxes (Topic 740):
+Added: of the Company’s Annual Report.
+Added: The Company uses the same accounting policies in preparing its quarterly and annual financial statements.
+Added: There have been no material changes to significant accounting policies during the three months ended March 31, 2025.
+Added: Use of Estimates
+Added: The preparation of the Company’s
+Added: condensed consolidated financial statements in conformity with U.S.
+Added: GAAP requires management to make estimates, assumptions, and
+Added: judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the condensed
+Added: consolidated financial statements and the reported amounts of income and expenses during the reporting periods.
+Added: Significant estimates
+Added: and assumptions reflected within these condensed consolidated financial statements include but are not limited to research and development
+Added: expenses and related prepaid or accrued costs and the valuation of stock-based compensation awards and related expenses.
+Added: The Company bases
+Added: its estimates on known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances.
+Added: On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts, and experience.
+Added: Actual results
+Added: could differ materially from those estimates or assumptions.
+Added: Recently Issued Accounting Pronouncements
+Added: In December 2023, the
+Added: FASB issued ASU 2023-09, Income Taxes (Topic 740):
Improvements to Income Tax Disclosures .
−Removed: This ASU expands disclosures in an entity’s income
−Removed: tax rate reconciliation table and disclosures regarding taxes paid both in the U.S.
+Added: This ASU expands disclosures
+Added: in an entity’s income tax rate reconciliation table and disclosures regarding taxes paid both in the U.S.
and foreign jurisdictions.
−Removed: This update is effective
−Removed: beginning with the Company’s 2025 fiscal year annual reporting period.
−Removed: The Company is currently evaluating the impact of the adoption
−Removed: of this ASU on its consolidated financial statements.
−Removed: In November 2024, the FASB issued ASU 2024-03,
−Removed: Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):
−Removed: Disaggregation of
−Removed: Income Statement Expenses .
−Removed: This ASU requires more detailed disclosures, on an annual and interim basis, about specified categories
−Removed: of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented on the face
−Removed: of the income statement.
−Removed: This ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years
−Removed: beginning after December 15, 2027.
+Added: This update is effective beginning with the Company’s 2025 fiscal year annual reporting period.
+Added: The Company is currently evaluating
+Added: the impact of the adoption of this ASU on its condensed consolidated financial statements.
+Added: In November 2024, the FASB
+Added: issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):
+Added: Disaggregation of Income Statement Expenses .
+Added: This ASU requires more detailed disclosures, on an annual and interim basis, about specified
+Added: categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented
+Added: on the face of the income statement.
+Added: This ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within
+Added: fiscal years beginning after December 15, 2027.
Early adoption is permitted.
This ASU may be applied either prospectively or retrospectively.
−Removed: is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements.
−Removed: Reverse Recapitalization and Pre-Closing Financing
−Removed: As described within the Reverse Recapitalization and Pre-Closing
−Removed: Financing section in Note 1, on August 29, 2024, the reverse recapitalization between Pre-Merger Oruka and ARCA was consummated.
−Removed: Merger was accounted for as a reverse recapitalization in accordance with U.S.
−Removed: At the effective time of the Merger, substantially
−Removed: all of the assets of ARCA consisted of cash and cash equivalents and other nominal non-operating assets and liabilities.
−Removed: No goodwill or
−Removed: intangible assets were recognized.
−Removed: As part of the recapitalization, the Company acquired the assets and
−Removed: liabilities listed below (in thousands):
−Removed: Cash and cash equivalents
−Removed: Other current assets
−Removed: Accrued liabilities
−Removed: Net assets acquired
+Added: The Company is currently evaluating the impact of the adoption of this ASU on its condensed consolidated financial statements.
Fair Value Measurements
−Removed: following tables present the Company’s fair value hierarchy for financial assets measured as of September 30, 2024 (in thousands):
−Removed: Fair Value Measurements as of September 30, 2024
−Removed: Financial assets:
+Added: The following tables present the Company’s
+Added: fair value hierarchy for financial assets measured as of March 31, 2025 and December 31, 2024 (in thousands):
+Added: March 31, 2025
+Added: Cash equivalents
Money market funds
−Removed: Total financial assets
−Removed: There were no transfers between Level 1,
−Removed: Level 2, or Level 3 during the period from February 6, 2024 (inception) to September 30, 2024.
−Removed: Expenses and Other Current Liabilities
−Removed: expenses and other current liabilities consisted of the following (in thousands):
−Removed: September 30,
+Added: government agency securities
+Added: Corporate debt securities
+Added: Commercial papers
+Added: Total cash equivalents
+Added: Marketable securities
+Added: Marketable securities, current
+Added: treasury securities
+Added: government agency securities
+Added: Commercial papers
+Added: Corporate debt securities
+Added: Total marketable securities, current
+Added: Marketable securities, long-term
+Added: treasury securities
+Added: government agency securities
+Added: Total marketable securities, long-term
+Added: Total cash equivalents and marketable securities
+Added: There were no transfers in or out of Level 3 during
+Added: the three months ended March 31, 2025.
+Added: December 31, 2024
+Added: Cash equivalents
+Added: Money market funds
+Added: treasury securities
+Added: government agency securities
+Added: Commercial papers
+Added: Total cash equivalents
+Added: Marketable securities
+Added: Marketable securities, current
+Added: treasury securities
+Added: government agency securities
+Added: Commercial papers
+Added: Corporate debt securities
+Added: Total marketable securities, current
+Added: Marketable securities, long-term
+Added: treasury securities
+Added: government agency securities
+Added: Total marketable securities, long-term
+Added: Total cash equivalents and marketable securities
+Added: Cash Equivalents and Marketable Securities
+Added: Cash equivalents and marketable securities, which
+Added: are classified as available-for-sale, consisted of the following as of March 31, 2025 and December 31, 2024 (in thousands):
+Added: March 31, 2025
+Added: Amortized Cost
+Added: Gross Unrealized Gains
+Added: Gross Unrealized Losses
+Added: Cash equivalents
+Added: Money market funds
+Added: government agency securities
+Added: Corporate debt securities
+Added: Commercial papers
+Added: Total cash equivalents
+Added: Marketable securities
+Added: Marketable securities, current
+Added: treasury securities
+Added: government agency securities
+Added: Commercial papers
+Added: Corporate debt securities
+Added: Total marketable securities, current
+Added: Marketable securities, long-term
+Added: treasury securities
+Added: government agency securities
+Added: Total marketable securities, long-term
+Added: Total cash equivalents and marketable securities
+Added: December 31, 2024
+Added: Amortized Cost
+Added: Gross Unrealized Gains
+Added: Gross Unrealized Losses
+Added: Cash equivalents
+Added: Money market funds
+Added: treasury securities
+Added: government agency securities
+Added: Commercial papers
+Added: Total cash equivalents
+Added: Marketable securities
+Added: Marketable securities, current
+Added: treasury securities
+Added: government agency securities
+Added: Commercial papers
+Added: Corporate debt securities
+Added: Total marketable securities, current
+Added: Marketable securities, long-term
+Added: treasury securities
+Added: government agency securities
+Added: Total marketable securities, long-term
+Added: Total cash equivalents and marketable securities
+Added: The following table summarizes the available-for-sale
+Added: securities in an unrealized loss position, aggregated by major security type and length of time in a continuous unrealized loss position,
+Added: for which an allowance for credit losses was not recorded as of March 31, 2025 and December 31, 2024 (in thousands):
+Added: March 31, 2025
+Added: Less than 12 months
+Added: 12 months or longer
+Added: Unrealized Losses
+Added: Unrealized Losses
+Added: Unrealized Losses
+Added: Cash equivalents
+Added: Commercial papers
+Added: Marketable securities
+Added: Marketable securities, current
+Added: treasury securities
+Added: government agency securities
+Added: Commercial papers
+Added: Corporate debt securities
+Added: Marketable securities, long-term
+Added: government agency securities
+Added: December 31, 2024
+Added: Less than 12 months
+Added: 12 months or longer
+Added: Unrealized Losses
+Added: Unrealized Losses
+Added: Unrealized Losses
+Added: Cash equivalents
+Added: Commercial papers
+Added: Marketable securities
+Added: Marketable securities, current
+Added: treasury securities
+Added: government agency securities
+Added: Corporate debt securities
+Added: Marketable securities, long-term
+Added: treasury securities
+Added: government agency securities
+Added: The Company evaluated its
+Added: securities for credit losses and considered the decline in market value to be primarily attributable to current economic and market conditions
+Added: and not to a credit loss or other factors.
+Added: Additionally, the Company does not intend to sell the securities in an unrealized loss position
+Added: and it is not more likely than not that the Company will be required to sell the securities before recovery of the unamortized cost basis,
+Added: which may be at maturity.
+Added: There were no material realized gains or realized losses on marketable securities for the periods presented.
+Added: Given the Company’s intent and ability to hold such securities until recovery, and the lack of significant change in credit risk
+Added: of these investments, the Company does not consider these marketable securities to be impaired as of March 31, 2025 and December 31, 2024.
+Added: As of March 31, 2025 and December 31, 2024, the Company did not record an allowance for credit losses.
+Added: The following table summarizes
+Added: the contractual maturities of the Company’s marketable securities at estimated fair value (in thousands):
+Added: Due in one year or less
+Added: Due in 1-2 years
+Added: Accrued Expenses and Other Current Liabilities
+Added: Accrued expenses and other current liabilities
+Added: consisted of the following (in thousands):
Accrued employee compensation and benefits
2 unchanged sentences
Note Payable with Related Party
−Removed: In March 2024, the Company entered into a
−Removed: Series A Preferred Stock and Convertible Note Purchase Agreement (the “Purchase Agreement”) with Fairmount Healthcare Fund II,
−Removed: (“Fairmount”), whereby the Company issued a convertible note (the “Convertible Note”), with an initial principal
−Removed: amount of $ 25.0 million that, at the time of issuance, could be converted into Pre-Merger Oruka Series A Preferred Stock (or a series of
−Removed: preferred shares that is identical in respect to the shares of preferred shares issued in its next equity financing) or shares of Pre-Merger
−Removed: Oruka Common Stock in exchange for aggregate proceeds of $ 25.0 million.
−Removed: The Convertible Note accrued interest at a rate of 12.0 %
−Removed: At issuance, the Convertible Note required all unpaid interest and principal to mature on December 31, 2025 (the “Maturity
−Removed: Date”) and prepayment was not permitted without prior written consent of Fairmount.
−Removed: At issuance, the principal payment along with
−Removed: the accrued interest on the Convertible Note was due in full on the Maturity Date.
−Removed: Company assessed all terms and features of the Convertible Note in order to identify any potential embedded features that would require
−Removed: As part of this analysis, the Company assessed the economic characteristics and risks of the embedded features.
−Removed: determined that the share settled redemption feature was clearly and closely related to the debt host and did not require separate accounting.
−Removed: The Company determined that the conversion options of the Convertible Note were not clearly and closely associated with a debt host.
−Removed: However, these features did not meet the definition of a derivative under ASC 815, Derivatives and Hedging , and as a result,
−Removed: did not require separate accounting as a derivative liability.
−Removed: Company paid debt issuance costs of less than $ 0.1 million in relation to the Convertible Note.
−Removed: The debt issuance costs were reflected
−Removed: as a reduction of the carrying value of Convertible Note on the condensed consolidated balance sheet and were being amortized as interest
−Removed: expense over the term of the Convertible Note using the effective interest method.
−Removed: For the three months ended September 30, 2024 and
−Removed: the period from February 6, 2024 (inception) to September 30, 2024, the Company recognized interest expenses related to the Convertible
−Removed: Note of $ 0.5 million and $ 1.5 million, respectively, which includes non-cash interest expense related to the amortization of debt issuance.
−Removed: Immediately prior to the completion of the Merger
−Removed: (see Note 1), the Convertible Note was converted into shares of Pre-Merger Oruka Common Stock based on the aggregate principal amount
−Removed: of $ 25.0 million, plus unpaid accrued interest of $ 1.5 million divided by the conversion price which was determined based upon the Company’s
−Removed: fully-diluted capitalization immediately prior to the Merger.
−Removed: At the effective time of the Merger, the Pre-Merger Oruka Common Stock issued
−Removed: upon the conversion of the Convertible Note (including accrued interest) automatically converted into 2,722,207 shares of Company Common
−Removed: As of September 30, 2024, the Convertible Note is not outstanding.
−Removed: Convertible Preferred Stock and Stockholders’ Equity
−Removed: In August 2024, pursuant to the Subscription Agreement and immediately
−Removed: prior to the Closing, certain new and current investors purchased pre-funded warrants, which, at the effective time of the Merger,
−Removed: were exercisable for 5,522,207 shares of Company Common Stock at a purchase price of approximately $ 9.70 per warrant.
−Removed: After the Merger,
−Removed: there are 5,522,207 pre-funded warrants outstanding and are exercisable for 5,522,207 shares of the Company Common Stock at an exercise
−Removed: price of $ 0.01 per share.
−Removed: In September 2024, in connection with the PIPE
−Removed: Financing, the Company issued and sold 680,000 pre-funded warrants, at a purchase price of $ 22.999 per warrant, exercisable for 680,000
−Removed: shares of Company Common Stock at an exercise price of $ 0.001 per share.
−Removed: pre-funded warrants were recorded as a component of stockholders’ equity within additional paid-in-capital and have no expiration
−Removed: As of September 30, 2024, none of the pre-funded warrants have been exercised and 6,202,207 pre-funded warrants remain outstanding.
−Removed: In July 2024, Pre-Merger Oruka entered into a Subscription Agreement
−Removed: that provided for, among other things, the issuance of warrants to certain of Pre-Merger Oruka’s employees, directors, and service
−Removed: providers immediately prior to the closing of the Merger.
−Removed: During the three months ended September 30, 2024, 3,054,358 employee warrants
+Added: In March 2024, Pre-Merger
+Added: Oruka entered into a Series A Preferred Stock and Convertible Note Purchase Agreement (the “Purchase Agreement”) with Fairmount
+Added: Healthcare Fund II, L.P.
+Added: (“Fairmount”), whereby Pre-Merger Oruka issued a convertible note (the “Convertible Note”),
+Added: with an initial principal amount of $ 25.0 million that, at the time of issuance, could be converted into Pre-Merger Oruka Series A
+Added: Preferred Stock (or a series of preferred shares that is identical in respect to the shares of preferred shares issued in its next
+Added: equity financing) or shares of Pre-Merger Oruka Common Stock in exchange for aggregate proceeds of $ 25.0 million.
+Added: The Convertible
+Added: Note accrued interest at a rate of 12.0 % per annum.
+Added: Immediately prior to the completion of the Merger (see Note 1), the Convertible Note
+Added: was converted into shares of Pre-Merger Oruka Common Stock based on the aggregate principal amount of $ 25.0 million, plus unpaid accrued
+Added: interest of $ 1.5 million divided by the conversion price which was determined based upon the Company’s fully-diluted capitalization
+Added: immediately prior to the Merger.
+Added: At the effective time of the Merger, the Pre-Merger Oruka Common Stock issued upon the conversion of
+Added: the Convertible Note (including accrued interest) automatically converted into 2,722,207 shares of Company Common Stock.
+Added: The Company assessed all
+Added: terms and features of the Convertible Note in order to identify any potential embedded features that would require bifurcation.
+Added: of this analysis, the Company assessed the economic characteristics and risks of the embedded features.
+Added: The Company determined that the
+Added: share settled redemption feature was clearly and closely related to the debt host and did not require separate accounting.
+Added: determined that the conversion options of the Convertible Note were not clearly and closely associated with a debt host.
+Added: However, these
+Added: features did not meet the definition of a derivative under ASC 815, Derivatives and Hedging, and as a result, did not require separate
+Added: accounting as a derivative liability.
+Added: The Company paid debt issuance costs of less than $ 0.1 million
+Added: in relation to the Convertible Note.
+Added: The debt issuance costs were reflected as a reduction of the carrying value of Convertible Note on
+Added: the consolidated balance sheet and were being amortized as interest expense over the term of the Convertible Note using the effective
+Added: interest method.
+Added: For the three months ended March 31, 2025 and the period from February 6, 2024 (inception) to March 31, 2024, the Company
+Added: recognized interest expenses related to the Convertible Note of nil and $ 0.2 million, respectively, which included non-cash interest expense
+Added: related to the amortization of debt issuance of less than $ 0.1 million.
+Added: As of December 31, 2024 and March 31, 2025, the Convertible Note
+Added: is not outstanding.
+Added: Preferred Stock and Stockholders’ Equity
+Added: In August 2024, pursuant
+Added: to the Subscription Agreement and immediately prior to the Closing, certain new and current investors purchased pre-funded warrants,
+Added: which, at the effective time of the Merger, were exercisable for 5,522,207 shares of Company Common Stock at a purchase price of approximately
+Added: $ 9.70 per warrant and after the Closing, are now exercisable for 5,522,207 shares of the Company Common Stock at an exercise price of
+Added: $ 0.01 per share.
+Added: In September 2024, in connection
+Added: with the PIPE Financing, the Company issued and sold 680,000 pre-funded warrants, at a purchase price of $ 22.999 per warrant, exercisable
+Added: for 680,000 shares of Company Common Stock at an exercise price of $ 0.001 per share.
+Added: The pre-funded warrants were
+Added: recorded as a component of stockholders’ equity within additional paid-in-capital and have no expiration date.
+Added: Collectively, 6,202,207
+Added: pre-funded warrants are outstanding as of March 31, 2025 and December 31, 2024.
+Added: Employee Warrants
+Added: The Subscription Agreement
+Added: provided for, among other things, the issuance of warrants to certain of Pre-Merger Oruka’s employees and directors immediately
+Added: prior to the closing of the Merger.
+Added: During the period from February 6, 2024 (inception) to December 31, 2024, 3,054,358 employee warrants
were issued at an exercise price of $ 7.80 per warrant.
−Removed: These employee warrants vest over a period of four years .
−Removed: Per the terms of the
−Removed: Employee Warrant Agreement, the holders of the Company’s employee warrants shall not have any of the rights or privileges of a stockholder
−Removed: of the Company in respect of any shares purchasable upon the exercise of the warrant or any portion thereof unless and until a certificate
−Removed: or certificates representing such shares have been issued or a book entry representing such shares has been made and such shares have
−Removed: been deposited with the appropriate registered book-entry custodian.
−Removed: The Company recognizes compensation cost related to employee warrants
−Removed: on a straight-line basis over the requisite service period, which is the period in which the related services are received.
−Removed: As of September
−Removed: 30, 2024, none of the employee warrants have been exercised and 3,054,358 employee warrants remain outstanding.
−Removed: Preferred Stock
−Removed: In March 2024, Pre-Merger Oruka issued and
−Removed: sold an aggregate of 20,000,000 shares of Pre-Merger Oruka Series A Preferred Stock to Fairmount (see Note 13), at a purchase price
−Removed: of approximately $ 0.15 per share, for aggregate gross proceeds of $ 3.0 million.
−Removed: Pre-Merger Oruka incurred less than $ 0.1 million
−Removed: of issuance costs in connection with this transaction.
−Removed: Upon the issuance of the Pre-Merger Oruka Series A Preferred Stock, the Company
−Removed: assessed the embedded conversion and liquidation features of the securities as described below and determined that such features did not
−Removed: require the Company to separately account for these features.
−Removed: In August 2024, upon the closing of the Merger, the Company converted
−Removed: the Pre-Merger Oruka Series A Preferred Stock to 137,138 shares of Company Series B Preferred Stock.
−Removed: In September 2024, in connection with the PIPE
−Removed: Financing, the Company issued and sold an aggregate of 2,439 shares of the Company Series A Preferred Stock at a purchase price of $ 23,000.00
−Removed: of September 30, 2024, convertible preferred stock consisted of the following (in thousands, except share data):
−Removed: September 30, 2024
−Removed: Preferred Stock
−Removed: Preferred Stock
−Removed: Issuable Upon
−Removed: Series A Non-Voting Preferred Stock
−Removed: Series B Non-Voting Preferred Stock
−Removed: Pursuant to the Certificate of Designation of Preferences,
−Removed: Rights and Limitations of the Series A Non-Voting Convertible Preferred Stock (the “Series A Certificate of Designation”)
−Removed: filed in connection with the PIPE Financing, holders of Company Series A Preferred Stock are entitled to receive dividends on shares of
−Removed: Company Series A Preferred Stock equal to, on an as-if-converted-to-Company Common Stock basis, and in the same form as, dividends actually
−Removed: paid on shares of Company Common Stock.
−Removed: Except as provided in the Series A Certificate of Designation or as otherwise required by law,
−Removed: the Company Series A Preferred Stock does not have voting rights.
−Removed: The Company Series A Preferred Stock shall rank on parity with the Company
−Removed: Common Stock and Company Series B Preferred Stock upon any liquidation, dissolution or winding-up of the Company.
−Removed: Subject to the terms
−Removed: and limitations contained in the Series A Certificate of Designation, the Company Series A Preferred Stock issued in the PIPE Financing
−Removed: will not become convertible until the Company’s stockholders approve the conversion of the Company Series A Preferred Stock into
−Removed: shares of Company Common Stock in accordance with the listing rules of the Nasdaq Stock Market (the “Stockholder Approval”), which resulted in the Company Series A Preferred Stock being classified
−Removed: outside of stockholders’ equity (deficit) on the Company’s condensed consolidated balance sheet.
−Removed: Following the Stockholder Approval, each share of Company Series A Preferred Stock will automatically convert into 1,000 shares of Company
−Removed: Common Stock, subject to certain limitations, including that shares of Company Series A Preferred Stock shall not be convertible if the
−Removed: conversion would result in a holder, together with its affiliates, beneficially owning more than 9.99 % of the Company’s outstanding
−Removed: shares of Company Common Stock as of the applicable conversion date, which may be increased at the holders’ option (not to exceed
−Removed: 19.99 %), effective in accordance with the terms of the Series A Certificate of Designation.
−Removed: If, at any time after the earlier of Stockholder
−Removed: Approval or six months after the initial issuance of the Series A non-voting preferred stock, the Company fails to deliver to a holder
−Removed: such certificate or certificates, the Company shall, at the request of the holder, pay an amount equal to the closing price of Company’s
−Removed: common stock on the trading day immediately prior to the date on which notice to conversion is received by the Company (the “Fair
−Removed: Value”) of such undelivered shares, with such payment to be made within two business days from the date of request by the holder,
−Removed: whereupon the Company’s obligations to deliver such shares underlying the notice of conversion shall be extinguished upon payment
−Removed: in full of the Fair Value of such undelivered shares;
−Removed: provided, however that such request shall be presumed to have been made by such
−Removed: holder if Stockholder Approval shall not have been obtained prior to the date on which the notice of conversion is delivered to the Company.
−Removed: Pursuant to the Certificate of Designation of Preferences, Rights and
−Removed: Limitations of the Series B Non-Voting Convertible Preferred Stock (the “Series B Certificate of Designation”) filed in connection
−Removed: with the Merger, holders of Company Series B Preferred Stock are entitled to receive dividends on shares of Company Series B Preferred
−Removed: Stock equal to, on an as-if-converted-to-Company Common Stock basis, and in the same form as, dividends actually paid on shares of Company
−Removed: Common Stock.
−Removed: Except as provided in the Series B Certificate of Designation or as otherwise required by law, the Company Series B Preferred
−Removed: Stock does not have voting rights.
−Removed: The Company Series B Preferred Stock shall rank on parity with the Company Common Stock as to the distribution
−Removed: of assets upon any liquidation, dissolution, or winding-up of the Company.
−Removed: Each share of Company Series B Preferred Stock is convertible
−Removed: at the option of the holder, at any time, and without the payment of additional consideration by the holder.
−Removed: As of September 30, 2024,
−Removed: each outstanding share of Company Series B Preferred Stock was convertible into common stock at a ratio of approximately 83.3332:1.
−Removed: As of September 30, 2024, the Certificate of Incorporation
−Removed: provides for 545,000,000 authorized shares of Company Common Stock.
−Removed: As of September 30, 2024, 34,988,550 shares of Company Common Stock
−Removed: were issued and outstanding, including 2,207,553 shares of RSAs issued and outstanding.
−Removed: of September 30, 2024, the Company had common stock reserved for future issuance as follows:
−Removed: September 30,
−Removed: Shares issuable on conversion of Company Series A Preferred Stock
+Added: These warrants vest over a period of four years .
+Added: The Company recognizes compensation
+Added: cost related to warrants on a straight-line basis over the requisite service period, which is the period in which the related services
+Added: are received.
+Added: 3,054,358 warrants are outstanding as of March 31, 2025 and December 31, 2024.
+Added: Convertible Preferred Stock
+Added: In March 2024, Pre-Merger
+Added: Oruka issued and sold an aggregate of 20,000,000 shares of Pre-Merger Oruka Series A Preferred Stock to Fairmount (see Note 13),
+Added: at a purchase price of approximately $ 0.15 per share, for aggregate gross proceeds of $ 3.0 million.
+Added: Pre-Merger Oruka incurred less
+Added: than $ 0.1 million of issuance costs in connection with this transaction.
+Added: Upon the issuance of the Pre-Merger Oruka Series A
+Added: Preferred Stock, the Company assessed the embedded conversion and liquidation features of the securities as described below and determined
+Added: that such features did not require the Company to separately account for these features.
+Added: In August 2024, upon Closing,
+Added: the Pre-Merger Oruka Series A Preferred Stock converted to 137,138 shares of Company Series B Preferred Stock.
+Added: In September 2024, in connection
+Added: with the PIPE Financing, the Company issued and sold an aggregate of 2,439 shares of the Company Series A Preferred Stock at a purchase
+Added: price of $ 23,000.00 per share.
+Added: In November 2024, the 2,439 shares of the Company Series A Preferred Stock were converted to 2,439,000
+Added: shares of Company Common Stock.
+Added: As of December 31, 2024 and March 31, 2025, there are no outstanding shares of Company Series A Preferred
+Added: As of March 31, 2025, Company Series B Preferred
+Added: Stock consisted of the following (in thousands, except share data):
+Added: March 31, 2025
+Added: Stock Issuable
+Added: Company Series B Preferred Stock
+Added: Pursuant to the Certificate
+Added: of Designation of Preferences, Rights and Limitations of the Series B Non-Voting Convertible Preferred Stock (the “Series B Certificate
+Added: of Designation”) filed in connection with the Merger, holders of Company Series B Preferred Stock are entitled to receive dividends
+Added: on shares of Company Series B Preferred Stock equal to, on an as-if-converted-to-Company Common Stock basis, and in the same form as,
+Added: dividends actually paid on shares of Company Common Stock.
+Added: Except as provided in the Series B Certificate of Designation or as otherwise
+Added: required by law, the Company Series B Preferred Stock does not have voting rights.
+Added: The Company Series B Preferred Stock shall rank on
+Added: parity with the Company Common Stock as to the distribution of assets upon any liquidation, dissolution, or winding-up of the Company.
+Added: Each share of Company Series B Preferred Stock is convertible at the option of the holder, at any time, and without the payment of additional
+Added: consideration by the holder.
+Added: As of March 31, 2025, each outstanding share of Company Series B Preferred Stock was convertible into common
+Added: stock at a ratio of approximately 83.3332:1 .
+Added: Paruka Warrant
+Added: On December 31, 2024, the
+Added: Company settled its 2024 obligations under the Paruka Warrant Obligation (defined below) by issuing Paruka Holding LLC (“Paruka”)
+Added: a warrant to purchase 596,930 shares of Company Common Stock at an exercise price of $ 19.39 per share.
+Added: The warrant has a term of 10 years,
+Added: is fully vested, and is exercisable in part or full at any time during the term of the warrant.
+Added: As of March 31, 2025, the warrant issued
+Added: under the Paruka Warrant Obligation is outstanding and unexercised.
+Added: See Note 8 for additional information on the Paruka Warrant Obligation.
+Added: As of March 31, 2025, the
+Added: Certificate of Incorporation provides for 545,000,000 authorized shares of Company Common Stock.
+Added: As of March 31, 2025, 37,440,510 shares
+Added: of Company Common Stock were issued and outstanding, including 2,207,553 shares of restricted common stock awards (“RSAs”)
+Added: issued and outstanding.
+Added: As of March 31, 2025 and December 31, 2024, the
+Added: Company had common stock reserved for future issuance as follows:
Shares issuable on conversion of Company Series B Preferred Stock
Shares issuable upon exercise of pre-funded warrants
+Added: Shares issuable upon exercise of warrant under the Paruka Warrant Obligation
Outstanding and issued stock options
3 unchanged sentences
Total shares of common stock reserved
−Removed: Stock-Based Compensation
2024 Equity Incentive Plan
−Removed: The 2024 Equity Incentive Plan (“2024 Plan”)
−Removed: was adopted by the board of directors of Pre-Merger Oruka on February 6, 2024.
−Removed: The 2024 Plan provided for Pre-Merger Oruka to grant
−Removed: stock options, restricted stock awards, restricted stock units, and other stock-based awards to employees, officers, directors, consultants,
−Removed: and advisors.
−Removed: Equity Incentive Stock options granted under the 2024 Plan generally vest over four years, subject to the participant’s
−Removed: continued service, and expire after ten years, although stock options have been granted with vesting terms less than four years.
−Removed: As of September 30, 2024, there are no shares of common stock available for issuance.
+Added: The 2024 Equity Incentive
+Added: Plan (“2024 Plan”) was adopted by the board of directors of Pre-Merger Oruka on February 6, 2024.
+Added: The 2024 Plan provided
+Added: for Pre-Merger Oruka to grant stock options, restricted stock awards, restricted stock units, and other stock-based awards to employees,
+Added: officers, directors, consultants, and advisors.
+Added: Equity incentive stock options granted under the 2024 Plan generally vest over four years,
+Added: subject to the participant’s continued service, and expire after ten years, although two non-employee stock options were granted
+Added: with vesting terms less than four years.
+Added: As of March 31, 2025, 1,179,193 shares were subject to options outstanding under the 2024
+Added: Plan and will become available under the 2024 Stock Incentive Plan (defined below) to the extent the options are forfeited or lapse unexercised.
2024 Stock Incentive Plan
−Removed: On August 22, 2024, the 2024 Stock Incentive Plan
−Removed: (“2024 Stock Plan”) was approved by the Company’s stockholders and on August 29, 2024, the board of directors of the
−Removed: Company (the “Board”) ratified the 2024 Stock Plan.
−Removed: The 2024 Stock Plan allows for the grant of stock options, stock appreciation
−Removed: rights, restricted stock awards, restricted stock units, other stockholder-based awards and incentive bonuses.
−Removed: The 2024 Stock Plan is
−Removed: administered by the Compensation Committee of the Board (the “Compensation Committee”) or another committee designated by
−Removed: the Board to administer the Plan.
−Removed: The initial share pool under the 2024 Stock Plan is 4,634,891 shares of Company Common Stock and as
−Removed: of September 30, 2024, there are 4,526,324 shares available in the pool.
−Removed: The shares that may be issued under the 2024 Stock Plan will
−Removed: be automatically increased on January 1 of each year beginning in 2025 and ending with a final increase on January 1, 2034 in an amount
−Removed: equal to 5 % of the diluted stock (including Company Common Stock, preferred stock and unexercised pre-funded warrants) on the preceding
−Removed: December 31, unless a lower, or no, increase is determined by the Compensation Committee.
−Removed: Current or prospective employees, officers,
−Removed: non-employee directors, and other independent service providers of the Company and its subsidiaries are eligible to participate in the
−Removed: 2024 Stock Plan.
+Added: On August 22, 2024, the 2024
+Added: Stock Incentive Plan (“2024 Stock Plan”) was approved by the Company’s stockholders and on August 29, 2024, the board
+Added: of directors of the Company (the “Board”) ratified the 2024 Stock Plan.
+Added: The 2024 Stock Plan allows for the grant of stock
+Added: options, stock appreciation rights, restricted stock awards, restricted stock units, other stockholder-based awards and incentive bonuses.
+Added: An additional 2,753,543 shares became available for issuance under the 2024 Stock Plan on January 1, 2025 as a result of the annual increase
+Added: pursuant to the evergreen provision.
+Added: As of March 31, 2025, 7,388,434
+Added: shares were reserved for issuance under the 2024 Stock Plan, of which 5,302,167 shares were available for future grant and 2,086,267 shares
+Added: were subject to outstanding options.
2024 Employee Stock Purchase Plan
−Removed: The 2024 Employee Stock Purchase Plan (the “ESPP”)
−Removed: was approved by the board of directors of ARCA on July 20, 2024, and by ARCA’s stockholders on August 22, 2024.
−Removed: The ESPP became
−Removed: effective on August 29, 2024, at which time 463,489 shares were reserved for issuance.
−Removed: The shares that may be issued under the ESPP will
−Removed: be automatically increased on January 1 of each year beginning in 2025 and ending with a final increase on January 1, 2034 in an amount
−Removed: equal to 1 % of the diluted stock (including Company Common Stock, preferred stock and unexercised pre-funded warrants) on the preceding
−Removed: December 31, unless a lower, or no, increase is determined by the Compensation Committee.
−Removed: As of September 30, 2024, no shares have been
−Removed: issued out of the ESPP.
−Removed: Option Valuation
−Removed: The following table summarizes the weighted-average
−Removed: assumptions used in calculating the fair value of the awards for the three months ended September 30, 2024 and for the period from February 6,
−Removed: 2024 (inception) to September 30, 2024:
−Removed: September 30,
+Added: The 2024 Employee Stock Purchase
+Added: Plan (the “ESPP”) became effective in August 2024.
+Added: Eligible employees may purchase shares of Company Common Stock under the
+Added: ESPP at 85 % of the lower of the fair market value of the Company Common Stock as of the first or the last day of each offering period.
+Added: Employees are limited to contributing 15 % of the employee’s eligible compensation and may not purchase more than $ 25,000 of
+Added: stock during any calendar year.
+Added: The ESPP will terminate ten years from the first purchase date under the plan, unless terminated
+Added: earlier by the board of directors.
+Added: An additional 550,709 shares became available for issuance under the ESPP on January 1, 2025 as a result
+Added: of the annual increase pursuant to the evergreen provision.
+Added: The Company issued no shares
+Added: during the three months ended March 31, 2025 out of the ESPP and as of March 31, 2025, there were 1,011,238 shares of Company Common Stock
+Added: available in the pool for future issuances.
+Added: For the three months ended
+Added: March 31, 2025, stock-based compensation expense related to the ESPP was less than $ 0.1 million.
+Added: Stock Option Valuation
+Added: The following table summarizes
+Added: the weighted-average assumptions used in calculating the fair value of the awards for the three months ended March 31, 2025 and for the
+Added: period from February 6, 2024 (inception) to March 31, 2024:
2025 Period from
−Removed: September 30,
+Added: (Inception) to
Expected term (in years) 6.0 6.0
2 unchanged sentences
Expected dividend yield —
−Removed: The following table summarizes the stock option activities under the
−Removed: 2024 Plan and 2024 Stock Plan for the period of February 6, 2024 (inception) through September 30, 2024:
−Removed: Stock Options Weighted
−Removed: Share Weighted
−Removed: Term (in Years) Aggregate
−Removed: Value (in Thousands)
−Removed: Balance as of February 6, 2024 (inception) —
+Added: Stock Options
+Added: The following table summarizes
+Added: the stock option activities under the 2024 Plan and the 2024 Stock Plan for the three months ended March 31, 2025:
+Added: Stock Options
+Added: Outstanding Weighted
+Added: Exercise Price
+Added: Per Share Weighted
+Added: (in Years) Aggregate
+Added: (in Thousands)
+Added: Balance as of December 31, 2024 1,567,760 $ 11.39 9.4 $ 15,470
Granted 1,697,700 $ 12.48
−Removed: Balance as of September 30, 2024 1,287,760 $ 7.97 9.6 $ 21,507
−Removed: Vested and expected to vest, September 30, 2024 1,287,760 $ 7.97 9.6 $ 21,507
−Removed: Exercisable, September 30, 2024 —
−Removed: The weighted average grant-date fair value per share of stock options
−Removed: granted during the period from February 6, 2024 (inception) to September 30, 2024 was $ 6.44 per share.
+Added: Canceled/forfeited —
+Added: Balance as of March 31, 2025 3,265,460 $ 11.96 9.5 $ 4,704
+Added: Vested and expected to vest, March 31, 2025 3,265,460 $ 11.96 9.5 $ 4,704
+Added: Exercisable, March 31, 2025 161,539 $ 7.77 9.3 $ 521
+Added: The weighted average grant-date
+Added: fair value per share of stock options granted during the three months ended March 31, 2025 was $ 9.88 per share.
Aggregate intrinsic value
1 unchanged sentence
in-the-money employee stock options.
−Removed: In February 2024 and March 2024, the Company
−Removed: issued 2,207,553 shares of RSAs to certain employees, directors, and consultants at a price of $ 0.0001 per share, the then par value of
−Removed: Pre-Merger Oruka Common Stock.
−Removed: Such RSAs have service-based vesting conditions only and vest over a four-year period, during which time
−Removed: all unvested shares are subject to forfeiture in the event the holder’s service with the Company voluntarily or involuntarily terminates.
−Removed: following table summarizes the RSAs activity for the period from February 6, 2024 (inception) through September 30, 2024:
−Removed: Unvested balance
−Removed: as of February 6, 2024 (inception)
−Removed: balance as of September 30, 2024
−Removed: Agreements and Paruka Warrant Obligation
−Removed: In March 2024, the Company entered into antibody
−Removed: discovery and option agreements with Paragon and Paruka (the “Option Agreements”).
−Removed: Under the terms of Option Agreements, Paragon
−Removed: identifies, evaluates, and develops antibodies directed against certain mutually agreed therapeutic targets of interest to the Company,
−Removed: and the Company has the exclusive option to, on a research program-by-research program basis, be granted an exclusive, worldwide license
−Removed: to all of Paragon’s right, title, and interest in and to the intellectual property resulting from the applicable research program
−Removed: to develop, manufacture and commercialize the antibodies and products directed to the selected target(s).
−Removed: Paruka will be entitled to grants
−Removed: of warrants to purchase a number of shares equal to 1.00 % of then outstanding shares of the Company’s stock, on a fully diluted
−Removed: basis, on December 31, 2024 and December 31, 2025, at the fair market value determined by the Board (the “Paruka Warrant
−Removed: Obligation”).
−Removed: The grant dates for the issuance of warrants are expected to be December 31, 2024 and December 31, 2025
−Removed: as all terms of the award, including number of shares and exercise price, will be known by all parties.
−Removed: The service inception period for
−Removed: the grant precedes the grant date, with the full award being vested as of the grant date with no post-grant date service requirement.
−Removed: Accordingly, the warrants expected to be granted to Paruka were accounted for as a liability on the condensed balance sheet and, after
−Removed: the initial recognition, the liability is adjusted to fair value at the end of each reporting period, with changes in fair value recorded
−Removed: in the statement of operations and comprehensive loss as stock-based compensation expenses under research and development expenses.
−Removed: of September 30, 2024, the estimated fair value of warrants to be granted on December 31, 2024 was $ 11.0 million.
−Removed: For the three months
−Removed: ended September 30, 2024 and the period from February 6, 2024 (inception) to September 30, 2024, $ 7.3 million and $ 7.7 million were
−Removed: recognized as stock-based compensation expenses related to the Paruka Warrant Obligation, respectively.
−Removed: As stated above, on July 3, 2024, the Subscription
−Removed: Agreement was amended and restated, among other things, for employee warrants to be issued to certain Pre-Merger Oruka’s employees,
−Removed: directors, and service providers, immediately prior to the closing of the Merger.
−Removed: Pursuant to this amendment, during the three months
−Removed: ended September 30, 2024, the Company issued 3,054,358 employee warrants at an exercise price of $ 7.80 per warrant, which are accounted
−Removed: as equity in the condensed consolidated financial statements
−Removed: following table summarizes the employee warrant activity for the period from February 6, 2024 (inception) through September 30, 2024:
−Removed: Warrants Weighted
−Removed: Price Per Share Weighted
−Removed: Term (in Years) Aggregate
−Removed: Value (in Thousands)
−Removed: Balance as of February 6, 2024 (inception) —
−Removed: Granted 3,054,358 $ 7.80
−Removed: Balance as of September 30, 2024 3,054,358 $ 7.80 9.8 $ 51,038
−Removed: Vested and expected to vest, September 30, 2024 3,054,358 $ 7.80 9.8 $ 51,038
−Removed: Vested and exercisable, September 30, 2024 —
−Removed: The weighted average grant-date fair value per share of employee warrants
−Removed: granted during the period from February 6, 2024 (inception) to September 30, 2024 was $ 6.27 per share.
−Removed: Aggregate intrinsic value
−Removed: represents the difference between the estimated fair value of the underlying Company Common Stock and the exercise price of outstanding,
−Removed: in-the-money employee warrants.
−Removed: The following table summarizes the weighted-average
−Removed: assumptions used in calculating the fair value of the employee warrants for the three months ended September 30, 2024 and for the period
−Removed: from February 6, 2024 (inception) to September 30, 2024:
−Removed: Three Months Ended
−Removed: September 30,
−Removed: 2024 Period from
−Removed: September 30,
−Removed: Expected term (in years) 6.1 6.1
−Removed: Expected volatility 99.0 % 99.0 %
−Removed: Risk-free interest rate 4.2 % 4.2 %
−Removed: Expected dividend yield —
−Removed: Compensation Expense
−Removed: following table summarizes the classification of the Company’s stock-based compensation expense in the condensed consolidated statement
−Removed: of operations and comprehensive loss (in thousands):
−Removed: Three Months Ended
−Removed: September 30,
−Removed: September 30,
+Added: Restricted Stock Awards
+Added: In February 2024 and March 2024,
+Added: the Company issued 2,207,553 shares of RSAs to certain employees, directors, and consultants at a price of $ 0.0001 per share, the then
+Added: par value of Pre-Merger Oruka Common Stock.
+Added: Such RSAs have service-based vesting conditions only and vest over a four-year period, during
+Added: which time all unvested shares are subject to forfeiture in the event the holder’s service with the Company voluntarily or involuntarily
+Added: 576,571 RSAs vested during the three months ended March 31, 2025 and as of March 31, 2025, 1,630,982 of the RSAs remain unvested.
+Added: For each of the three months ended March 31, 2025 and from February 6, 2024 (inception) to March 31, 2024, stock-based compensation expense
+Added: related to RSAs was less than $ 0.1 million.
+Added: The following table summarizes
+Added: the RSA activity for the three months ended March 31, 2025:
+Added: Number of RSAs
+Added: Weighted Average
+Added: Grant Date Fair
+Added: Unvested balance as of December 31, 2024
+Added: Unvested balance as of March 31, 2025
+Added: Option Agreements and Paruka Warrant Obligation
+Added: As part of the Option Agreements, (defined in Note 10 below) on December 31,
+Added: 2024 the Company granted, and on December 31, 2025, will grant, Paruka a warrant to purchase a number of shares equal to 1.00 % of
+Added: outstanding shares as of the date of the grant on a fully-diluted basis, with an exercise price equal to the fair market value of the
+Added: underlying shares on the grant date (the “Paruka Warrant Obligation”).
+Added: The grant dates for the issuance
+Added: of warrants were expected to be December 31, 2024 and December 31, 2025 as all terms of the award, including number of shares
+Added: and exercise price, will be known by all parties.
+Added: The Company determined that the 2024 and 2025 grants are two separate grants, as there
+Added: would be no obligation for the 2025 grant had the Company exercised or terminated all of the options under the Option Agreements prior
+Added: to December 31, 2024.
+Added: The service inception period for the grant precedes the grant date, with the full award being vested as of the grant
+Added: date with no post-grant date service requirement.
+Added: Accordingly, the warrant expected to be granted to Paruka was accounted for as a liability
+Added: on the balance sheet on the service inception date and, after the initial recognition, the liability is adjusted to fair value at the
+Added: end of each reporting period, with changes in fair value recorded in the condensed consolidated statement of operations and comprehensive
+Added: loss as stock-based compensation expenses under research and development expenses.
+Added: For the period from February 6, 2024 (inception) to
+Added: March 31, 2024, less than $ 0.1 million was recognized as stock-based compensation expenses related to the December 31, 2024 Paruka Warrant
+Added: On issuance of the warrant to Paruka on December 31, 2024, the fair value of the warrant issued on December 31, 2024 of $ 10.4
+Added: million was reclassified from liability to equity on the condensed consolidated balance sheet as of December 31, 2024.
+Added: As of March 31, 2025, the
+Added: estimated fair value of the warrant to be granted on December 31, 2025 was $ 5.6 million.
+Added: For the three months ended March 31, 2025 $ 1.4
+Added: million was recognized as stock-based compensation expenses related to the December 31, 2025 Paruka Warrant Obligation.
+Added: As of March 31,
+Added: 2025, there was $ 4.2 million in unamortized expense related to the December 31, 2025 Paruka Warrant Obligation.
+Added: Employee Warrants
+Added: As stated above, in July
+Added: 2024, the Subscription Agreement was amended and restated, among other things, for employee warrants to be issued to certain Pre-Merger
+Added: Oruka employees and directors prior to the Closing.
+Added: During the period from February 6, 2024 (inception) to December 31, 2024, the Company
+Added: issued 3,054,358 warrants at an exercise price of $ 7.80 per warrant, which are accounted as equity in the condensed consolidated financial
+Added: The employee warrants were subject to performance and service based vesting requirements and upon completion of the Merger
+Added: the performance-based requirements had been achieved.
+Added: During the three months ended March 31, 2025, no employee warrants were granted.
+Added: The following table summarizes
+Added: the employee warrant activity during the three months ended March 31, 2025:
+Added: Outstanding Weighted
+Added: Exercise Price
+Added: Per Share Weighted
+Added: (in Years) Aggregate
+Added: (in Thousands)
+Added: Balance as of December 31, 2024 3,054,358 $ 7.80 9.5 $ 35,400
+Added: Canceled/forfeited —
+Added: Balance as of March 31, 2025 3,054,358 $ 7.80 9.3 $ 7,514
+Added: Vested and expected to vest, March 31, 2025 3,054,358 $ 7.80 9.3 $ 7,514
+Added: Exercisable, March 31, 2025 —
+Added: Stock-Based Compensation Expense
+Added: The following table summarizes
+Added: the classification of the Company’s stock-based compensation expense in the condensed consolidated statements of operations and
+Added: comprehensive loss (in thousands):
+Added: (Inception) to
Research and development
General and administrative
−Removed: As of September 30, 2024, total unrecognized compensation cost related
−Removed: to the unvested stock options was $ 7.5 million, which is expected to be recognized over a weighted average period of approximately 3.4
−Removed: As of September 30, 2024, total unrecognized compensation cost related to the unvested RSAs was less than $ 0.1 million, which is
−Removed: expected to be recognized over a weighted average period of 3.4 years.
−Removed: As of September 30, 2024, the unrecognized compensation cost related
−Removed: to the employee warrants was $ 17.8 million, which is expected to be recognized over a weighted average period of 3.6 years.
−Removed: following table summarizes the award types of the Company’s stock-based compensation expense in the condensed consolidated statement
−Removed: of operations and comprehensive loss (in thousands):
−Removed: Three Months Ended
−Removed: September 30,
−Removed: September 30,
+Added: As of March 31, 2025, total
+Added: unrecognized compensation cost related to the unvested stock options was $ 27.6 million, which is expected to be recognized over a weighted
+Added: average period of approximately 3.4 years.
+Added: As of March 31, 2025, total
+Added: unrecognized compensation cost related to the unvested RSAs was less than $ 0.1 million, which is expected to be recognized over a weighted
+Added: average period of 2.9 years.
+Added: As of March 31, 2025, the
+Added: unrecognized compensation cost related to the employee warrants was $ 14.7 million, which is expected to be recognized over a weighted
+Added: average period of 3.1 years.
+Added: The following table summarizes
+Added: the award types of the Company’s stock-based compensation expense in the condensed consolidated statements of operations and comprehensive
+Added: loss (in thousands):
+Added: (Inception) to
Paruka Warrant Obligation
2 unchanged sentences
Employee stock purchase plan
−Removed: provision for income taxes was recorded for the three months ended September 30, 2024 and for the period of February 6, 2024 (inception)
−Removed: through September 30, 2024.
−Removed: Deferred tax assets generated from the Company’s net operating losses have been fully reserved, as
−Removed: the Company believes it is not more likely than not that the benefit will be realized due to the Company’s cumulative losses generated
−Removed: Option Agreements
−Removed: In March 2024, the Company entered into Option
−Removed: Agreements with Paragon and Paruka.
−Removed: Under the terms of the Option Agreements, Paragon identifies, evaluates and develops antibodies directed
−Removed: against certain mutually agreed therapeutic targets of interest to the Company.
−Removed: The Option Agreements include two selected targets, IL-23
−Removed: (“ORKA-001”) and IL-17 A/F (“ORKA-002”).
−Removed: Under the Option Agreements, the Company has the exclusive options to,
−Removed: on a research program-by-research program basis, be granted an exclusive, worldwide license to all of Paragon’s right, title and
−Removed: interest in and to the intellectual property resulting from the applicable research program to develop, manufacture and commercialize
−Removed: the antibodies and products directed to the selected targets (each, an “Option”), with the exception of pursuing ORKA-001
−Removed: for the treatment of inflammatory bowel disease.
−Removed: If the Company exercises its options, it will be required to make non-refundable milestone
−Removed: payments to Paragon of up to $ 12.0 million under each respective agreement upon the achievement of certain clinical development milestones,
−Removed: up to $ 10.0 million under each respective agreement upon the achievement of certain regulatory milestones as well as tiered royalty
−Removed: payments in the low-to-mid single-digits beginning on the first commercial sale.
−Removed: From time to time, the Company can choose to add additional
−Removed: targets to the collaboration by mutual agreement with Paragon.
−Removed: Company’s exclusive Option with respect to each research program for a particular target initiated by the parties (“Research
−Removed: Program”) is exercisable at its sole discretion at any time during the period beginning on the initiation of activities under the
−Removed: associated Research Program and ending a specified number of days following (i) with respect to any Research Program other than
−Removed: ORKA-001, the delivery of the data package from Paragon related to the results of the Research Plan activities, or (ii) with respect
−Removed: to ORKA-001, the completion of the IL-23 antibody selection process described in the agreement (the “Option Period”).
−Removed: is no payment due upon exercise of an Option pursuant to the Option Agreements.
−Removed: Unless terminated earlier, the Option Agreements
−Removed: shall continue in force on a Research Program-by-Research Program basis until the earlier of:
−Removed: (i) the end of the Option Period for
−Removed: such Research Program, as applicable, if such Option is not exercised by the Company;
−Removed: (ii) the expiration of the 30-day period after
−Removed: the Company exercises its Option with respect to such Research Program, subject to mutually agreed extension, during the Option Period
−Removed: and the parties are unable to finalize and execute a license agreement, and (iii) the expiration of the applicable research term (the
−Removed: Upon the expiration of the Term for all then-existing Research Programs, under the Option Agreements, the Option
−Removed: Agreements will automatically expire in its entirety.
−Removed: The Company may terminate the Option Agreements or any Research Program at any
−Removed: time for any or no reason upon 30 days’ prior written notice to Paragon, provided that the Company must pay certain unpaid
−Removed: fees due to Paragon upon such termination, as well as any non-cancellable obligations reasonably incurred by Paragon in connection with
−Removed: its activities under any terminated Research Program.
−Removed: Paragon may terminate the Option Agreements or a Research Program immediately upon
−Removed: written notice to the Company if, as a result of any action or failure to act by the Company or its affiliates, such Research Program
−Removed: or all material activities under the applicable Research Plan are suspended, discontinued or otherwise delayed for a certain consecutive
−Removed: number of months.
−Removed: Each party has the right to terminate the Option Agreements or any Research Program upon (i) 30 days’
−Removed: prior written notice of the other party’s material breach that remains uncured for the 30-day period and (ii) the other party’s
−Removed: Pursuant to the Option Agreements, on a research
−Removed: program-by-research program basis following the finalization of the research plan for each respective research program, the Company was
−Removed: required to pay Paragon a one-time, nonrefundable research initiation fee of $ 0.8 million related to the ORKA-001 program.
−Removed: was recognized as a research and development expense during the period from February 6, 2024 (inception) to September 30, 2024.
−Removed: June 2024, pursuant to the Option Agreements with Paragon, the Company completed the selection process of its development candidate for
−Removed: IL-23 antibody for ORKA-001 program.
−Removed: The Company was responsible for 50 % of the development costs incurred through the completion of the
−Removed: IL-23 selection process.
−Removed: The Company received the rights to at least one selected IL-23 antibody in June 2024.
−Removed: During the three months
−Removed: ended September 30, 2024, the Company exercised its option for ORKA-001 and recorded a $ 1.5 million milestone payment related to the achievement
−Removed: of development candidate as research and development expense in the Company’s condensed consolidated statements of operations and
−Removed: comprehensive loss for each of the three months ended September 30, 2024 and for the period from February 6, 2024 (inception) to September
−Removed: The Company’s share of development costs incurred during the three months ended September 30, 3024 and for the period
−Removed: from February 6, 2024 (inception) to September 30, 2024 was $ 0.8 million and $ 13.2 million, respectively, which were recorded as research
−Removed: and development expenses during the respective periods.
−Removed: An amount of $ 2.3 million is included in related party accounts payable and other
−Removed: current liabilities as of September 30, 2024.
−Removed: The Company was also required to reimburse Paragon
−Removed: $ 3.3 million for development costs related to ORKA-002 incurred by Paragon through December 31, 2023 and certain other development
−Removed: costs incurred by Paragon between January 1, 2024 and March 6, 2024 as stipulated by the Option Agreements.
−Removed: This amount was
−Removed: recognized as a research and development expense during the period from February 6, 2024 (inception) to September 30, 2024.
−Removed: is also responsible for the development costs incurred by Paragon from January 1, 2024 through the completion of the IL-17 selection
−Removed: The Company recognized an amount of $ 0.8 million payable to Paragon for the research initiation fee related to ORKA-002
−Removed: following the finalization of the ORKA-002 research plan.
−Removed: This was recognized as research and development expenses in the period from
−Removed: February 6, 2024 (inception) to September 30, 2024.
−Removed: The Company accounted for development costs of $ 3.8 million and $ 6.6 million during
−Removed: the three months ended September 30, 3024 and for the period from February 6, 2024 (inception) to September 30, 2024, respectively, as
−Removed: research and development expenses during the respective periods.
−Removed: An amount of $ 3.8 million is included in related party accounts payable
−Removed: and other current liabilities as of September 30, 2024.
−Removed: As part of the Option Agreements, on each of December
−Removed: 31, 2024 and December 31, 2025, the Company will grant warrants to purchase a number of shares equal to 1.00 % of outstanding shares as
−Removed: of the date of the grant on a fully diluted basis with an exercise price equal to the fair market value of the underlying shares on the
−Removed: The warrants are liability-classified and after the initial recognition, the liability is adjusted to fair value at the end
−Removed: of each reporting period, with changes in fair value recorded in the consolidated statement of operations and comprehensive loss (see
−Removed: Note 8) as stock-based compensation expenses under research and development expenses.
−Removed: Company expenses the service fees as the associated costs are incurred when the underlying services are rendered.
−Removed: Such amounts are classified
−Removed: within research and development expenses in the accompanying condensed consolidated statement of operations and comprehensive loss.
−Removed: The Company concluded that the rights obtained
−Removed: under the Option Agreements represent an asset acquisition whereby the underlying assets comprise in-process research and development
−Removed: assets with no alternative future use.
−Removed: The Option Agreements did not qualify as a business combination because substantially all of the
−Removed: fair value of the assets acquired was concentrated in the exclusive license options, which represent a group of similar identifiable assets.
−Removed: The research initiation fee represents a one-time cost on a research program-by-research program basis for accessing research services
−Removed: or resources with benefits that are expected to be consumed in the near term, therefore the amounts paid are expensed as part of research
−Removed: and development costs immediately.
−Removed: Amounts paid as reimbursements of ongoing development cost, monthly development cost fee and additional
−Removed: development expenses incurred by Paragon due to work completed for selected targets prior to the effective date of the Option Agreements
−Removed: that is associated with services being rendered under the related Research Programs are recognized as research and development expense
−Removed: when incurred.
−Removed: For the three months ended September 30, 2024 and the period from February 6,
−Removed: 2024 (inception) to September 30, 2024, the Company recognized $ 13.4 million and $ 33.8 million of expenses, respectively, in connection
−Removed: with services provided by Paragon and Paruka under the Option Agreements.
+Added: The Company operates and
+Added: manages its business activities on a consolidated basis and operates in one reportable segment.
+Added: The Company operates as a
+Added: single reportable and operating segment.
+Added: Its Chief Executive Officer, serving as the Chief Operating Decision Maker (“CODM”),
+Added: oversees operations on an aggregated basis to allocate resources effectively.
+Added: In assessing the Company’s financial performance,
+Added: the CODM regularly reviews total operating expenses and consolidated net loss.
+Added: The measure of segment assets
+Added: is reported on the balance sheet as total consolidated assets.
+Added: The Company’s long-lived assets consist primarily of property and
+Added: equipment, net.
+Added: As of March 31, 2025 and December 31, 2024 all of long-lived assets were in the U.S.
+Added: The table below is a summary
+Added: of the segment loss from operations, including significant segment expenses (in thousands):
+Added: (Inception) to
+Added: Research and development personnel-related (excluding stock-based compensation)
+Added: General and administrative personnel-related (excluding stock-based compensation)
+Added: Research and development stock-based compensation
+Added: General and administrative stock-based compensation
+Added: External research and development
+Added: Other research and development
+Added: General and administrative, excluding personnel-related and stock-based compensation
+Added: Total operating expenses
+Added: Loss from operations
+Added: Option Agreements and License Agreements
+Added: Option Agreements – Paragon Therapeutics
+Added: In March 2024, the Company
+Added: entered into two antibody discovery and option agreements (“Option Agreements”) with Paragon Therapeutics, Inc.
+Added: Under the terms of each agreement, Paragon identifies, evaluates, and develops antibodies directed against certain mutually
+Added: agreed therapeutic targets of interest to the Company.
+Added: From time to time, the Company can choose to add additional targets to the collaboration
+Added: upon agreement with Paragon and Paruka.
+Added: Under the Option Agreements, the Company has the exclusive option to, on a research program-by-research
+Added: program basis, be granted an exclusive, worldwide license to all of Paragon’s right, title, and interest in and to the intellectual
+Added: property resulting from the applicable research program to develop, manufacture, and commercialize the antibodies and products directed
+Added: to the selected target(s).
+Added: The Company has initiated certain research programs with Paragon that generally focus on discovering,
+Added: generating, identifying and/or characterizing antibodies directed to a particular target (each, a “Research Program”), including
+Added: for IL-23 and IL-17A/F for ORKA-001 and ORKA-002, respectively.
+Added: The exclusive option with respect to each Research Program is exercisable
+Added: at the Company’s sole discretion at such time as specified in the Option Agreements (the “Option Period”).
+Added: no payment due upon exercise of an Option pursuant to the Option Agreements.
+Added: For each of these agreements, once the Company enters into
+Added: the corresponding license agreements, it will be required to make non-refundable milestone payments to Paragon of up to $ 12.0 million
+Added: under each respective agreement upon the achievement of certain clinical development milestones, up to $ 10.0 million under each respective
+Added: agreement upon the achievement of certain regulatory milestones, as well as a low single-digit percentage royalty for antibody products
+Added: beginning on the first commercial sale in each program.
+Added: The Company may terminate
+Added: any Option Agreement or any Research Program at any time for any or no reason upon 30 days’ prior written notice to Paragon,
+Added: provided that it must pay certain unpaid fees due to Paragon upon such termination, as well as any non-cancellable obligations reasonably
+Added: incurred by Paragon in connection with its activities under any terminated Research Program.
+Added: Paragon may terminate any Option Agreement
+Added: or a Research Program immediately upon written notice to the Company if, as a result of any action or failure to act by the Company or
+Added: its affiliates, such Research Program or all material activities under the applicable Research Plan are suspended, discontinued or otherwise
+Added: delayed for a certain consecutive number of months.
+Added: Each party has the right to terminate the Option Agreements or any Research Program
+Added: upon material breach that remains uncured or the other party’s bankruptcy.
+Added: License Agreements – Paragon Therapeutics
+Added: In September 2024, the Company
+Added: exercised its exclusive option to acquire certain rights to ORKA-001, and in December 2024, it entered into a corresponding license agreement
+Added: with Paragon (the “ORKA-001 License Agreement”), pursuant to which Paragon granted the Company a royalty-bearing, world-wide,
+Added: exclusive license to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting IL-23 in all fields
+Added: other than the field of inflammatory bowel disease (“ORKA-001 Field”).
+Added: In December 2024, the Company exercised its exclusive
+Added: option to acquire certain rights to ORKA-002, and in February 2025, it entered into the corresponding license agreement with Paragon (the
+Added: “ORKA-002 License Agreement” and together with the ORKA-001 License Agreement, the “License Agreements”), pursuant
+Added: to which Paragon granted the Company a royalty-bearing, world-wide, exclusive license to develop, manufacture, commercialize or otherwise
+Added: exploit certain antibodies and products targeting IL-17A/F in all fields (“ORKA-002 Field” and together with the ORKA-001
+Added: Field, the “Fields”).
+Added: Pursuant to each of the two License Agreements, Paragon has agreed not to conduct any new campaigns
+Added: that generate anti-IL-23 monospecific antibodies or anti-IL-17A/F monospecific antibodies in the respective agreed-upon fields.
+Added: The License Agreements provide
+Added: the Company with exclusive licenses in the Fields to Paragon’s patent applications covering the related antibodies, their method
+Added: of use and their method of manufacture and Paragon has agreed not to conduct any new campaigns that generate anti-IL-23 monospecific antibodies
+Added: or anti-IL-17A/F monospecific antibodies for the ORKA-001 Field or the ORKA-002 Field, respectively, for at least five years.
+Added: the License Agreements may be terminated on 60 days’ notice to Paragon, on material breach without cure, and on a party’s
+Added: insolvency or bankruptcy to the extent permitted by law.
+Added: Pursuant to the terms of each of the License Agreements,
+Added: the Company is obligated to pay Paragon non-refundable milestone payments of up to $ 12.0 million under each respective agreement upon
+Added: the achievement of certain clinical development milestones and up to $ 10.0 million under each respective agreement upon the achievement
+Added: of certain regulatory milestones.
+Added: In addition, the Company is obligated to pay Paragon a low single-digit percentage royalty for antibody products
+Added: for each of ORKA-001 and ORKA-002.
+Added: For each of the License Agreements, the royalty term ends on the later of (i) the last-to-expire licensed
+Added: patent or our patent directed to the manufacture, use or sale of a licensed antibody in the country at issue or (ii) 12 years from the
+Added: date of first sale of a Company product.
+Added: There is also a royalty step-down if there is no Paragon patent in effect during the royalty
+Added: term for each program.
+Added: Each of the License Agreements may be terminated on 60 days’ notice to Paragon, on material breach without
+Added: cure, and on a party’s insolvency or bankruptcy to the extent permitted by law.
+Added: As of March 31, 2025, the Company has incurred and
+Added: expensed milestone payments of $ 4.0 million and $ 1.5 million for ORKA-001 License Agreement and ORKA-002 License Agreement, respectively.
+Added: Additionally, as part of
+Added: the Option Agreements, on December 31, 2024 the Company granted and on December 31, 2025, will grant Paruka a warrant to purchase
+Added: a number of shares equal to 1.00 % of outstanding shares as of the date of the grant on a fully-diluted basis, with an exercise price equal
+Added: to the fair market value of the underlying shares on the grant date.
+Added: Pursuant to the Option Agreements,
+Added: on a research program-by-research program basis following the finalization of the research plan for each respective research program,
+Added: the Company is required to pay certain initiation fees, development costs and milestone payments to Paragon.
+Added: For the ORKA-001 program,
+Added: the Company recognized research and development expenses related to the following milestones during the period from February 6, 2024 (inception)
+Added: to December 31, 2024:
+Added: a one-time, nonrefundable research initiation fee of $ 0.8 million;
+Added: $ 1.5 million related to exercising its option
+Added: and achievement of development candidate;
+Added: and $ 2.5 million related to completing the first dosing of a human subject in a Phase 1 trial.
+Added: The Company was responsible for 50 % of the development costs incurred through the completion of the IL-23 selection process which was
+Added: completed in June 2024.
+Added: For the ORKA-002 program,
+Added: the Company recognized research and development expenses related to the following milestones during the period from February 6, 2024 (inception)
+Added: to December 31, 2024:
+Added: a one-time, nonrefundable research initiation fee of $ 0.8 million and $ 1.5 million related to exercising its option
+Added: and achievement of development candidate.
+Added: The Company was responsible for the development costs incurred through the completion of the
+Added: IL-23 selection process which was completed in December 2024.
+Added: Pursuant to the Option Agreements,
+Added: during the three months ended March 31, 2025 and the period from February 6, 2024 (inception) to March 31, 2024, the Company’s share
+Added: of development costs incurred for ORKA-001 program for the periods were nil and $ 0.8 million, respectively, which were recorded as research
+Added: and development expenses.
+Added: As of March 31, 2025 and December 31, 2024, nil and $ 2.8 million, respectively, related to ORKA-001 were included
+Added: in related party accounts payable and other current liabilities.
+Added: Pursuant to the Option Agreements,
+Added: the Company recognized $ 0.1 million and $ 4.2 million as research and development expenses for ORKA-002 program during the three months
+Added: ended March 31, 2025 and the period from February 6, 2024 (inception) to March 31, 2024, respectively.
+Added: As of March 31, 2025 and December
+Added: 31, 2024, $ 0.1 million and $ 2.7 million, respectively, related to ORKA-002 were included in related party accounts payable and other current
+Added: For the three months ended
+Added: March 31, 2025 and the period from February 6, 2024 (inception) to March 31, 2024, the Company recognized $ 1.5 million and $ 5.0 million,
+Added: respectively, of expenses in connection with services provided by Paragon and Paruka under the Option Agreements.
+Added: The Company expenses the
+Added: service fees as the associated costs are incurred when the underlying services are rendered.
+Added: Such amounts are classified within research
+Added: and development expenses in the accompanying condensed consolidated statements of operations and comprehensive loss.
+Added: The Company concluded that
+Added: the rights obtained under the Option Agreements represent an asset acquisition whereby the underlying assets comprise in-process research
+Added: and development assets with no alternative future use.
+Added: The Option Agreements did not qualify as a business combination because substantially
+Added: all of the fair value of the assets acquired was concentrated in the exclusive license options, which represent a group of similar identifiable
+Added: The research initiation fee represents a one-time cost on a research program-by-research program basis for accessing research
+Added: services or resources with benefits that are expected to be consumed in the near term, therefore the amounts paid are expensed as part
+Added: of research and development costs immediately.
+Added: Amounts paid as reimbursements of ongoing development cost, monthly development cost fee
+Added: and additional development expenses incurred by Paragon due to work completed for selected targets prior to the effective date of the
+Added: Option Agreements that is associated with services being rendered under the related Research Programs are recognized as research and development
+Added: expense when incurred.
Commitment and Contingencies
−Removed: April 2024, the Company entered into an operating lease agreement for the Company’s headquarters in Menlo Park, California, which
−Removed: commenced on June 15, 2024 with an initial term of 39.5 months.
−Removed: The Company leases office space under this noncancelable operating lease
−Removed: Lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term.
−Removed: In determining
−Removed: the present value of lease payments, the Company used its incremental borrowing rate when measuring operating lease liabilities as discount
−Removed: rates were not implicit or readily determinable.
−Removed: As of September 30, 2024, the Company had $ 0.9
−Removed: million of operating lease right-of-use assets, operating lease liability, current of $ 0.1 million, and operating lease liability, noncurrent
−Removed: of $ 0.8 million on its condensed consolidated balance sheets.
−Removed: As of September 30, 2024, the operating lease arrangement had a remaining
−Removed: lease term of 36.0 months and a discount rate of 17.95 %.
−Removed: For the three months ended September 30, 2024 and the period from February 6,
−Removed: 2024 (inception) to September 30, 2024, the Company recorded operating and variable lease expense of $ 0.1 and $ 0.2 million, respectively,
−Removed: in general and administrative expenses in its condensed consolidated statements of operations and comprehensive loss.
−Removed: following table presents the Company’s supplemental cash flow information related to leases (in thousands):
−Removed: paid for amounts included in the measurement of lease liabilities
−Removed: cash flow from operating leases
−Removed: following table summarizes a maturity analysis of the Company’s operating lease liabilities showing the aggregate lease payments
−Removed: as of September 30, 2024 (in thousands):
−Removed: Fiscal year ending December 31,
−Removed: 2024 (remainder)
+Added: In April 2024, the Company
+Added: entered into an operating lease agreement for the Company’s headquarters in Menlo Park, California, which commenced on June 15,
+Added: 2024 with an initial term of 39.5 months.
+Added: The Company leases office space under this noncancelable operating lease agreement.
+Added: Lease liabilities
+Added: are based on the net present value of the remaining lease payments over the remaining lease term.
+Added: In determining the present value of
+Added: lease payments, the Company used its incremental borrowing rate when measuring operating lease liabilities as discount rates were not
+Added: implicit or readily determinable.
+Added: As of March 31, 2025, the
+Added: operating lease arrangement had a remaining lease term of 30 months and a discount rate of 17.95 %.
+Added: For the three months ended March 31,
+Added: 2025, the Company recorded operating and variable lease expense of $ 0.1 million in general and administrative expenses in its condensed
+Added: consolidated statement of operations and comprehensive loss.
+Added: The following table presents
+Added: the Company’s supplemental cash flow information related to leases (in thousands):
+Added: Cash paid for amounts included in the measurement of lease liabilities
+Added: The following table summarizes a maturity analysis
+Added: of the Company’s operating lease liabilities showing the aggregate lease payments as of March 31, 2025 (in thousands):
+Added: Year ending December 31,
+Added: 2025 (remainder of the year)
Total undiscounted lease payments
3 unchanged sentences
Non-current portion of lease liability
+Added: In February 2025, the Company
+Added: entered into a lease agreement for office space in Waltham, Massachusetts.
+Added: This operating lease commenced on April 1, 2025 with an initial
+Added: term of 54 months.
+Added: The Company expects to pay approximately $ 1.6 million over the lease term.
+Added: Cell Line License Agreement
+Added: In March 2024, the Company
+Added: entered into the Cell Line License Agreement (the “Cell Line License Agreement”) with WuXi Biologics Ireland Limited (“WuXi
+Added: Under the Cell Line License Agreement, the Company received a non-exclusive, worldwide, sublicensable license to certain
+Added: of WuXi Biologics’ know-how, cell line, biological materials (the “WuXi Biologics Licensed Technology”) and media and
+Added: feeds to make, have made, use, sell and import certain therapeutic products produced through the use of the cell line licensed by WuXi
+Added: Biologics under the Cell Line License Agreement (the “WuXi Biologics Licensed Products”).
+Added: Specifically, the WuXi Biologics
+Added: Licensed Technology is used in certain manufacturing activities in support of the ORKA-001 and ORKA-002 programs.
+Added: In consideration for the
+Added: license, the Company agreed to pay WuXi Biologics a non-refundable license fee of $ 150,000 , which was recognized as a research and development
+Added: expense during the period from February 6, 2024 (inception) to December 31, 2024.
+Added: Additionally, to the extent that the Company manufactures
+Added: its commercial supplies of bulk drug product with a manufacturer other than WuXi Biologics or its affiliates, the Company is required
+Added: to make royalty payments to WuXi Biologics at a rate of less than one percent of net sales of WuXi Biologics Licensed Products manufactured
+Added: by the third-party manufacturer.
+Added: Pursuant to an amendment to the Cell Line License Agreement effective in November 2024, a provision was
+Added: added that permits the royalties owed under the agreement to be bought out on a product-by-product basis for a lump-sum payment.
+Added: The Cell Line License Agreement
+Added: will continue indefinitely unless terminated (i) by the Company upon six months’ prior written notice and its payment of all undisputed
+Added: amounts due to WuXi Biologics through the effective date of termination, (ii) by WuXi Biologics for a material breach by the Company that
+Added: remains uncured for 60 days after written notice, (iii) by WuXi Biologics if the Company fails to make a payment and such failure continues
+Added: for 30 days after receiving notice of such failure, or (iv) by either party upon the other party’s bankruptcy.
+Added: Legal Proceedings
+Added: The Company is not currently
+Added: party to any material legal proceedings.
+Added: At each reporting date, the Company evaluates whether or not a potential loss amount or a potential
+Added: range of loss is probable and reasonably estimable under the provisions of FASB ASC Topic 450, Contingencies (“ASC 450”).
+Added: The Company expenses as incurred the costs related to its legal proceedings.
Net Loss per Share
1 unchanged sentence
to stockholders were calculated as follows (in thousands, except share and per share data):
−Removed: Three Months Ended
−Removed: September 30,
−Removed: September 30,
−Removed: Loss Allocation
−Removed: Weighted Average Shares Outstanding
−Removed: Loss Per Share – Basic and Diluted
+Added: Three Months Ended March 31, 2025
+Added: February 6, 2024 (Inception) to
+Added: March 31, 2024
Loss Allocation
−Removed: Weighted Average Shares Outstanding
−Removed: Loss Per Share – Basic and Diluted
−Removed: Company Series A Preferred Stock (1)
−Removed: $ ( 1,460.62 )
−Removed: $ ( 6,077.13 )
Company Series B Preferred Stock (1)
−Removed: weighted-average number of shares of as-converted Company Series A Preferred Stock used in the loss allocation was 477,196 and 184,462
−Removed: for the three months ended September 30, 2024 and for the period from February 6, 2024 (inception) to September 30, 2024, respectively.
−Removed: weighted-average number of shares of as-converted Company Series B Preferred Stock used in the loss allocation was 4,099,227 and 1,584,575
−Removed: for the three months ended September 30, 2024 and for the period from February 6, 2024 (inception) to September 30, 2024, respectively.
−Removed: For the computation of basic net loss per share
−Removed: attributable to stockholders, the amount of weighted-average shares outstanding excludes all shares of unvested restricted common stock
−Removed: as such shares are not considered outstanding for accounting purposes until vested.
−Removed: The amount of weighted-average shares outstanding
−Removed: includes the pre-funded warrants as the exercise price is negligible and these warrants are fully vested and exercisable.
−Removed: The potential shares of common stock that were
−Removed: excluded from the computation of diluted net loss per share attributable to stockholders for the periods presented because including them
−Removed: would have had an anti-dilutive effect were as follows:
−Removed: Three Months Ended
−Removed: September 30,
−Removed: September 30,
+Added: (1) The weighted-average number of shares of as-converted Company Series B Preferred Stock used in the loss allocation was 11,428,129 for the three months ended March 31, 2025.
+Added: For the computation of basic
+Added: net loss per share attributable to stockholders, the amount of weighted-average shares outstanding excludes all shares of unvested restricted
+Added: common stock as such shares are not considered outstanding for accounting purposes until vested.
+Added: The amount of weighted-average shares
+Added: outstanding includes the pre-funded warrants as the exercise price is negligible and these warrants are fully vested and exercisable.
+Added: The potential shares of common
+Added: stock that were excluded from the computation of diluted net loss per share attributable to stockholders for the periods presented because
+Added: including them would have had an anti-dilutive effect were as follows:
Outstanding employee warrants to purchase common stock
1 unchanged sentence
Outstanding and issued common stock options
−Removed: Related Party Transactions
−Removed: Paragon and Paruka each beneficially own less
−Removed: than 5 % of the Company’s capital stock through their respective holdings of Company Common Stock.
−Removed: Fairmount beneficially owns more than 5 % of the
−Removed: Company’s capital, currently has one representative appointed to the Board, and beneficially owns more than 5 % of Paragon.
−Removed: appointed Paragon’s board of directors and has the contractual right to approve the appointment of any executive officers of Paragon.
−Removed: following is a summary of related party accounts payable and other current liabilities (in thousands):
−Removed: September 30,
+Added: Outstanding and issued warrant to Paruka
+Added: Party Transactions
+Added: Paragon and Paruka each beneficially
+Added: own less than 5% of the Company’s capital stock through their respective holdings of Company Common Stock.
+Added: Fairmount beneficially owns
+Added: more than 5% of the Company’s capital, currently has one representative appointed to the Board, and beneficially owns more than
+Added: 5% of Paragon.
+Added: Fairmount appointed Paragon’s board of directors and has the contractual right to approve the appointment of any
+Added: executive officers of Paragon.
+Added: The following is a summary
+Added: of related party accounts payable and other current liabilities (in thousands):
Paragon reimbursable Option Agreements’ fees
+Added: Paragon milestone payments for Option Agreement
Paragon reimbursable other research expenses
1 unchanged sentence
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.